Nucleus Arthroplasty Volume I

Nucleus
Arthroplasty
Technology
in Spinal Care
Volume I: Fundamentals
Table of Contents
1
Introduction
About the Editors
CHAPTER 1
How the Disc Degenerates
CHAPTER 2
10
Nucleus Arthroplasty Motion Preservation Technology
CHAPTER 3
12
Nucleus Arthroplasty Technology from the U.S. Regulatory Viewpoint
CHAPTER 4
17
Fundamentals of Reimbursement
CHAPTER 5
21
Worldwide Orthopedic and Spine Market
CHAPTER 6
27
Nucleus Arthroplasty Technologies
35
Conclusion
36
Contributing Authors
versus Nucleus Replacement
his monograph series is a groundbreaking project in the

rapidly emerging field of non-fusion spinal surgery. The
full range of nucleus replacement technologies is examined
with discussion on surgical techniques, detailed information
on each cutting-edge device technology, indications, and
patient selection criteria.
Nucleus Arthroplasty Technology in Spinal Care is
published for the medical profession by Raymedica, LLC,
Minneapolis, MN 55431.
The views expressed in this series are those of the authors
and do not necessarily represent those of Raymedica, LLC.
Copyright 2006 Raymedica, LLC. All rights reserved.
Printed in U.S.A.
Introduction
Reginald J. Davis, MD, FACS
Federico P. Girardi, MD
CHIEF OF NEUROSURGERY
ASSISTANT PROFESSOR
Baltimore Neurosurgical Associates, PA

Baltimore, MD 21204
OF ORTHOPEDIC SURGERY
Hospital for Special Surgery

New York, NY 10021
he first documented works describing the diagnosis and

treatment of the spine, spinal disorders, and spinal instability
date back to 1900-2500 B.C. Interestingly, the documents recommended against the treatment of spinal cord injury. The development of therapeutic treatments has a long history starting with
the cane, the first load-sharing device. Today, our efforts to
improve therapies to treat spine disease persist. We continue to
recognize problems, identify issues, and define variables in an
effort to better understand spinal degeneration and to develop
innovative solutions that utilize a wide array of materials and
technologies. Our field has had a rich history of advancements,
accomplishments, and inventiveness. We owe a great debt to the
pioneers who, armed with little more than a detailed knowledge
of anatomy, heralded in the era of spinal surgery. Their trials,
errors, innovations, and teachings have guided our efforts to
ultimately improve clinical outcomes.
appreciation of pathological processes, such as disc degeneration,

and provide the ability to monitor the results of an intervention.
Computerized finite element analysis offers a risk-free environment
in which to test hypotheses and predict clinical impact. Biochemical
advancements yield an intimate understanding of the chemical environment including chemical mediators and potential intervention
portals. This wealth of knowledge can be used to great advantage
when developing disc arthroplasty technologies.
Early on, it was recognized that the disc played a vital role in overall
spine health. With great effort and ingenuity, the unique anatomical,
biomechanical, and physiological properties of the disc were elucidated and incorporated into elegant treatment algorithms. We now
have access to an almost overwhelming flow of information about
lumbar disc arthroplasty from countless sources. Central to the evolution of therapies is a better appreciation of the complexities of the
lumbar disc. By combining knowledge gleaned from anatomical dissection, biochemical processes, and resultant physiology with a disciplined foundation in biomechanics, we have created a fabric of
understanding never before enjoyed. Spine arthroplasty is now an
important and evolving area within the treatment of spinal disorders. This sub-discipline represents the coalescence of many areas of
study focused on the development of new and exciting solutions to
address clinical problems.
This publication has been constructed to provide an overview

of the foundational elements of Nucleus Arthroplasty motion
preservation technology including an understanding of the
degenerative process, current treatment solutions, systematic
treatment approaches, regulatory processes, and reimbursement
concerns. In addition, part one of this series will provide insight
into the potential market and the current players working in the
forefront of Nucleus Arthroplasty development activities. This is
an incredibly exciting field as technologies focused on the repair
and replacement of the diseased disc nucleus will catapult us far
beyond the treatment options we have available today.
These significant advances in our understanding of the spine represent a culmination of efforts occurring across many fronts. Our
increased understanding of the biological factors at work in disc
disease has been a driving force in the development and emergence of new materials and delivery methods. The critical role
that advanced biocompatible alloys, polymers, and viscoelastic
hydrogels play in the innovation of disc arthroplasty technologies
cannot be over emphasized.
Technological advancements have played a vital role in supporting
and expanding our knowledge of motion preserving disc technologies. The latest imaging technologies allow a much more detailed
Not to be overlooked, the socioeconomic challenges involved in the

development of new technologies, such as the Nucleus Arthroplasty
motion preservation system, have also become more apparent.
The all important variable of proper patient selection continues to
require constant reassessment and vigilance. Increasingly, third-party
payers control access to care and treatment choice to an alarming
degree. Such considerations can no longer be ignored in the quest
for ideal patient management methods.
In conclusion, we can say that the spine arthroplasty specialist

of today is well prepared to deliver the most advanced solutions
to the clinical puzzle of disc disease with technologies based on
a rich tradition of innovation and compassion coupled with a
tremendous wealth of physiological knowledge and assessment
tools. As spine surgery evolves from mechanical solutions to
therapeutic solutions both surgeons and patients will benefit.
We hope you will find this series on Nucleus Arthroplasty
technology to be a valuable asset.
1
About the Editors
aymedica has selected Reginald J. Davis, MD, FACS and

Federico P. Girardi, MD, to edit this series of monographs
on Nucleus Arthroplasty technology, because of their special

interest in this dynamic area of medicine. Both Drs. Davis and
Girardi are noted for their expertise in spine surgery and
advanced training in minimally invasive surgical techniques.
They are well respected for their clinical work and travel
widely to speak and train other physicians.
Dr. Davis is founder of Baltimore Neurosurgical Associates, chief

of Neurosurgery at the Greater Baltimore Medical Center, and a
faculty member at the Johns Hopkins School of Medicine and
the University of Maryland. He is a Fellow of the American
College of Surgeons and a Diplomate of the American Board
of Surgery. Dr. Davis received his medical degree from Johns
Hopkins University School of Medicine, Baltimore, Maryland.
Dr. Girardi is assistant attending orthopedic surgeon at the

Hospital for Special Surgery, New York, New York where he specializes in the treatment of spinal disorders including degenerative disc disease (DDD), spinal deformities, metabolic fractures,
and spinal tumors. Dr. Girardi received his medical degree from
the Universidad Nacional de Rosario, Rosario, Argentina.
He has broad experience in advanced procedures such as spinal

stabilization, intradiscal electrothermal therapy, and microendoscopic discectomy and has conducted physician training programs on these procedures. His professional affiliations include
the AANS-CNS Section on Disorders of the Spine, the American
Association of Neurological Surgeons, the Congress of
Neurological Surgeons, and the North American Spine Society.
He has performed extensive clinical research in the areas of minimally invasive surgery, clinical outcomes, and spinal imaging.
He is also interested in basic research on bone, disc, and nerve
tissue regeneration and in the investigation of alternatives to
spinal fusion for the treatment of DDD. His professional affiliations include the North American Spine Society, Scoliosis
Research Society, the European Spine Society, the International
Society for the Study of the Lumbar Spine, and the Spine
Arthroplasty Society.
Chapter 1
How the Disc Degenerates
Jeff S. Silber, MD
Archit Patel, MD
ASSISTANT PROFESSOR
SPINE RESEARCH FELLOW
Department of Orthopaedic Surgery

Chief, Division of Spine Surgery
Long Island Jewish Medical Center
New Hyde Park, NY 11040

The Rothman Institute
Philadelphia, PA 19107
Kamal Dagly, MD
Ravi Patel
RESIDENT ORTHOPAEDIC SURGERY
MEDICAL STUDENT

Long Island Jewish Medical Center
New Hyde Park, NY 11040

Thomas Jefferson University
Zoe Brown, MD
Alexander R. Vaccaro, MD
SPINE RESEARCH FELLOW
PROFESSOR

Department of Orthopaedics and Neurosurgery

Co-Chief, Division of Spine Surgery
Co-Spine Fellowship Director
Co-Director Delaware Valley Regional
Spinal Cord Injury Center and
MOLECULAR BIOLOGY OF DISC DEGENERATION
n understanding of the biology of disc degeneration can

provide a better understanding of the diagnosis and treatment of low back pain (LBP). The 23 intervertebral discs that lie
between each vertebral segment provide flexibility and increase
physically in size when progressing from the cervical spine to the
sacrum.1 The disc consists of two distinct anatomic regions that
work in unison. They include the fibrous outer annulus fibrosus
and the softer inner cartilaginous nucleus pulposus. The annulus
fibrosus in the lumbar spine has up to 25 layers known as
3
THE LUMBAR INTERVERTEBRAL DISC

HAS DEVELOPED THE ABILITY
P H Y L O G E N E T I C A L LY T O W I T H S TA N D
HIGH COMPRESSIVE AXIAL FORCES.
lamella containing mostly type I collagen arranged in a parallel

pattern.2 The intricate cross-linked configuration of the fibrils
allows the intervertebral disc to resist tensile forces incurred during lumbar spine bending and torsional movements. The inner
nucleus pulposus contains predominantly type II collagen fibers
arranged in a more random fashion. The fibers are surrounded
by a matrix rich in proteins known as proteoglycans. These proteoglycans bind water and have a high water content in a normal
intervertebral disc. This gives the disc its characteristic stiffness
and viscoelasticity allowing compressive resistance to axial loads.3
The concentration of proteoglycans and the water binding capacity of the disc increases when progressing from the outer annulus
fibrosus to the inner nucleus pulposus. In contrast, the concentration of type II collagen decreases from the inner nucleus to outer
annulus fibrosus. The collagen content of the nucleus is highest
in the cervical spine and decreases in the lumbar spine, while the
proteoglycan content increases in the lumbar spine. The high proteoglycan content in the lumbar spine is ideal due to its water
binding capacity, which allows for an increased resistance to axial
compressive loads where it is most needed.
Over time, proteolytic damage to the fibrillar collagens of the
annulus occurs as a result of collagenase activity. This leads to
a decrease in collagen cross-linking and a weakening in the biomechanical stability of the intervertebral disc and acceleration
of the normal process of disc degeneration or aging. As the disc
ages, the amount of aggregated proteoglycans decreases while
the content of non-aggregated proteoglycans increases leading to
lower osmotic or water binding capacity and a loss of compressive
resistance in the lumbar intervertebral disc.4
The vascularity of the intervertebral disc diminishes as it develops
and grows. The predominant source of intervertebral nutrition
during normal growth is through the vasculature of the vertebral
endplates. However in the adult, calcification of the endplates
occurs, and nutrient uptake and waste elimination occur through

diffusion. This leads to anaerobic metabolism taking a more
prominent role during which lactate production produces an
acidic environment, making proteinases more active and resulting
in further disc degeneration.5
The lumbar intervertebral disc has developed the ability phylogenetically to withstand high compressive axial forces. This is accomplished by its ability to convert compressive loads into tensile
stresses by utilizing the osmotic pressure of the interstitial fluid
and the proteoglycans located in the nucleus pulposus. As the disc
degenerates further, the annulus fibrosus becomes stiffer and the
osmotic pressure of the nucleus pulposus decreases causing imbalances in load transfer and resulting in increased stresses to the
bony elements of the vertebral endplates. It has been shown that
when heavy loads are applied to the intervertebral disc, the normal
disc biology is disrupted leading to an increase in catabolic
enzymes and an acceleration in intervertebral disc degeneration.6
Certain individuals may be genetically predisposed to the catabolic
events of disc degeneration. Polymorphisms of the vitamin D
receptor, aggrecan gene, type IX collagen, and MMP-3 (matrix
metalloproteinase-3) have all been implicated in accelerated
intervertebral disc degeneration. Furthermore, studies have
shown increased rates of degenerative disc disease in siblings
of affected individuals and a strong correlation in twins.
Chronic discogenic back pain has been linked to many factors
including anatomic structural changes, inflammatory mediators,
and nervous ingrowth into the outer annulus fibrosus. Production
of inflammatory mediators such as interleukin (IL)-1, IL-8,
fibroblast growth factor and intracellular adhesion molecule
(ICAM)-1 by mononuclear cells infiltrating a herniated disc may
also lead to inflammation and pain.7 IL-1 has also been shown to
increase the rate of matrix breakdown as well as decrease the production of proteoglycans, thereby, affecting the water content in
the nucleus pulposus. Additionally, herniated discs also produce
nitric oxide synthetase, an enzyme known to lead to the formation
of free radicals which cause direct damage to cell membranes and
matrix proteins.8 These herniated disc fragments can also generate
high levels of phospholipase A2, an enzyme which facilitates the
formation of pro-inflammatory prostaglandins and leukotrienes
both of which are important mediators in the production of pain.
STAGES OF DISC DEGENERATION
Stage II (Instability)
Kirkaldy-Willis described the widely accepted degenerative cascade (pathophysiological model) that occurs in the intervertebral
disc. The cascade is divided into three stages based on the
amount of damage or degeneration to the disc and facet joints at
a given point in time.9 This cascade of individual motion segment
degeneration is thought of as a continuum rather than as three
clearly definable and separate stages.
The second stage, known as the instability stage, represents more

severe tissue damage. This stage occurs later in life between 30
and 50 years of age. Intervertebral disc changes occur as the
result of multiple annular tears and delamination of the layers.
Vertebral segment instability occurs, and this results in a decline
in the amount of nuclear proteoglycan composition with a
resulting loss of water content. Increased force transfer to the
annulus occurs with the subsequent loss of intervertebral disc
height. The patient in this stage of degeneration also presents
with periods of low back pain which is usually more intense,
more protracted in duration and requires more aggressive intervention. These episodes occur more frequently, and MRI studies
reveal further loss of intervertebral disc height, a darker disc,
and possibly a herniation.
Stage I (Dysfunctional)
The first stage is known as the dysfunctional stage and occurs
when the initial changes of intervertebral disc degeneration begin.
This occurs between 20-30 years of age and is described by circumferential fissuring or tearing of the outer annulus fibrosus.
This may result from repetitive vertebral endplate injury leading
to a disruption in the intervertebral vascular supply and impairment of the normal disc metabolism. These pathophysiologic
changes result from years of repetitive microtrauma and usually
present as acute mechanical low back pain episodes or going out
phases. In the initial stages, acute episodes of low back pain are
self limited, and improve with minimal intervention. However,
the pain experienced in this stage may be severely debilitating
because of the large innervation to the outer-third of the annulus
via the sinuvertebral nerves. Over time, the circumferential tears
may combine and form larger radial tears while the inner nucleus
pulposus loses its water-retaining properties due to changes in
aggregating proteoglycans. These changes, mostly a decrease in
amount and organization in proteoglycans, are thought to occur
due to an imbalance in the MMP-3 (matrix metalloproteinase-3)
and TIMP-1 (tissue inhibitor of metalloproteinase-1) proteins
seen in the normal nucleus pulposus. Magnetic resonance imaging
(MRI) studies during this stage may reveal a high intensity zone
(HIZ) lesion in the posterior outer annulus fibrosus and decreased
signal intensity on T2 weighted images (disc desiccation) with or
without disc bulging and without herniation.
Stage II (Instability)
Figure 1
Stage II: A lateral plain radiograph demonstrating partial
loss of disc height at the L5-S1
interspace. There is radiographic
evidence of vertebral body
endplate deformation and early
anterior osteophyte formation.
Figure 2
Stage II: Sagittal MRI demonstrating decreased disc T2 signal intensity at both the L4-L5
and L5-S1 levels as a result of
disc desiccation. There is also
loss of disc space height at
these levels.
Stage III (Stabilization)
Figure 4
Figure 3
Stage III: Lateral radiograph of
the lumbar spine with significant loss of disc height at the
L4-L5 interval. Sclerosis is seen
at the vertebral endplates and
within the facet joints.
Stage III (Stabilization)

The third stage, known as the stabilization stage, is the endpoint
in the intervertebral disc degenerative cascade and is exemplified
by endstage tissue damage and attempts at repair. Further nucleus
pulposus resorption occurs with worsening intervertebral disc
space narrowing, fibrosis, endplate irregularities, and the formation of osteophytes. This stage usually occurs after the age of 60
and may present with symptoms of neurogenic claudication or
radiculopathy from central, lateral recess, and/or foraminal
stenosis. Lower extremity symptoms may prevail over low back
pain in this stage.
DIAGNOSIS
The relationship of lumbar disc degeneration and LBP remains
controversial. This is due to the poor correlation between the
presence of degenerative disc disease (DDD) on imaging studies
and the report of symptoms in the general population. Numerous
studies have documented that a high percentage of asymptomatic
patients have abnormal findings on imaging studies including the
Stage III: Sagittal MRI demonstrating markedly decreased T2 signal at

the L4-L5 disc space resulting from
endstage disc desiccation. Mildly
increased T2 signal is seen in the
adjacent L4 and L5 vertebral bodies
consistent with edema.
presence of DDD.10-15 However, some authors have reported a

strong correlation between low back pain and the presence of
a HIZ lesion seen in the outer annulus fibrosus. This finding is
thought to represent an annular tear which may lead to symptomatic DDD and LBP.16-20 In contrast, Carragee et al20 looked at
the incidence of HIZ annular tears on MRI in a recent prospective study. He reported the presence of a HIZ lesion in 42 symptomatic patients with LBP but also in 54 asymptomatic patients.
The prevalence of a HIZ lesion was 59% in the symptomatic
group and 24% in the asymptomatic group. The authors concluded that the prevalence of a HIZ lesion in asymptomatic
individuals with DDD was exceedingly high, and the presence
of an HIZ lesion was not meaningful for clinical use.20
Although approximately 80% of adults will experience low back
pain, only 1-2% will undergo an invasive surgical procedure. The
decision to undertake surgical management of DDD is extremely
patient dependent and requires great study due to the ubiquitousness of imaging evidence of spinal degenerative disease. The
pre-surgical work-up should include a thorough history relating
to any spinal complaints and a physical examination followed by
a working diagnosis and directed imaging studies. Imaging studies may include plain radiographs, MRI, computed tomography,
and provocative discography. The relative indications for the
surgical management of lumbar DDD for primarily axial back
pain include the following:
1. Chronic low back pain of discogenic origin for more than
six months that has failed a reasonable comprehensive nonoperative treatment program. This non-operative treatment
program may include physical therapy, chiropractic manipulation, activity modification, a back education program,
oral medications, and/or epidural spinal injections.
2. The absence of neurological signs and symptoms (radicular
findings).
3. Evidence of abnormal disc morphology or DDD on MRI.
4. A concordantly positive provocative discogram which
includes normal control levels above and/or below the
degenerative disc in question.
5. A reasonably normal psychological profile including an
appropriate, educated, and motivated patient that has realistic goals and expectations.21 A pre-surgical psychological
evaluation may also be strongly advised.
INTERBODY STABILIZATION (FUSION) PROCEDURES

At present, lumbar interbody fusion procedures are the primary
surgical treatment alternative for symptomatic lumbar degenerative
disc disease.22-27 Interbody fusion techniques include stand alone
Anterior Lumbar Interbody Fusion (ALIF), stand alone Posterior
Lumbar Interbody Fusion (PLIF), instrumented (pedicle screw)
Posterior Lumbar Interbody Fusion, Transforaminal Lumbar
Interbody Fusion (TLIF), and anterior/posterior or circumferential
fusions. Which fusion technique results in the highest fusion rate,
the fewest complications, and the best outcomes is continuously
debated among surgeons. Some spine surgeons favor anterior or
posterior-only approaches, while others favor an anterior/posterior
circumferential fusion procedure. Interbody fusion procedures have
been shown to be biomechanically superior to posterolateral intertransverse fusions alone in providing support against axial loads.23
INTERBODY FUSION PROCEDURES HAVE BEEN

S H O W N T O B E B I O M E C H A N I C A L LY S U P E R I O R
T O P O S T E R O L AT E R A L I N T E R T R A N S V E R S E
FUSIONS ALONE IN PROVIDING SUPPORT
AGAINST AXIAL LOADS.
6. No litigation/workers compensation claims.
PROCEDURAL CHOICES
If the patient is eligible for surgical intervention, a decision must
be made on the appropriate surgical procedure. The surgical procedure must address the proposed pain generator which is usually the intervertebral disc. Many surgical strategies have resulted
in less than satisfactory long-term outcomes. This has led to the
development of newer alternative technologies including nucleus
pulposus replacement, lumbar intervertebral disc replacement,
annular fibrosus augmentation, intradiscal electrothermal annuloplasty (IDET), and interbody fusion techniques. Currently, the
favored treatment methods involve removing the pain generator,
the intervertebral disc, through a fusion procedure and using a
variety of bone graft alternatives/extenders or maintaining
motion with an intervertebral disc arthroplasty.
Interbody fusion devices or cages come in a variety of shapes and

may be trapezoidal, ramped, lordotic, or cylindrical and are placed
either as a single device or paired. They can be inserted from
either an anterior or posterior approach. Minimally invasive cage
introduction methods designed to decrease surgical morbidity and
improve functional outcomes have been introduced.
The use of stand-alone cages without adjunctive pedicle screw
instrumentation has met with an unacceptable rate of failure
due to continued instability or symptomatic pseudarthrosis, especially when used over multiple segments or in the setting of circumferential instability (spondylolisthesis, lateral listhesis).25
The most predictable method of ensuring an interbody fusion is
a 360-degree or combined anterior and posterior spinal fusion.
Interestingly, surgeons continue to debate whether a solid fusion
is necessary to achieve a satisfactory outcome or whether a stable
interspace alone is sufficient.
Anterior surgical procedures may be performed using open or
laproscopic methods. The theoretical advantage of placing an
anterior interbody cage as compared with a posterior interbody
fusion technique is that it optimizes the ability to prepare the
intervertebral endplates through direct visualization.
7
S T U D I E S H AV E S H O W N T H AT A S I N G L E
O B L I Q U E C A G E P L A C E D A N T E R I O R LY
W I T H S U P P L E M E N TA L P E D I C L E S C R E W
I N S T R U M E N TAT I O N A P P R O X I M AT E S T H E
STIFFNESS AND STRENGTH OF A NORMAL
I N TA C T S P I N A L S E G M E N T.
Additionally, anterior placement provides a biomechanical advantage in restoring lumbar lordosis more efficiently. An anterior
approach often allows for placement of a much larger spacer than a
posterior delivered cage, because there is no need to retract neural
elements. Some surgeons also feel that there is a benefit in avoiding
surgical trauma to the posterior paraspinal musculature. The anterior approach, however, has its own unique complications including
the possibility of retrograde ejaculation, vascular and abdominal
visceral injuries, and post-operative incisional hernias.
The transforaminal lumbar interbody fusion (TLIF) allows placement of an interbody device from the posterior approach but more
laterally than the typical PLIF technique. The proposed advantage
of the TLIF over the PLIF technique is the minimal need for neural
retraction required for cage placement. Originally, the TLIF technique called for placement of two interbody devices through a
bilateral approach. However, it is quite frequently performed by
placing a single obliquely oriented interbody cage through a unilateral approach. The TLIF approach allows access to the intervertebral disc space lateral to the thecal sac. Studies have shown that
anterior placement of a single oblique cage using supplemental
pedicle screw instrumentation approximates the stiffness and
strength of a normal intact spinal segment.28 Adjunctive posterior pedicle screw instrumentation is always recommended when
performing a TLIF procedure, as it is with a PLIF.
The standard surgical exposure for posterior interbody fusions
usually involves a posterior midline incision and bilateral
paraspinal soft tissue dissection in order to expose the posterior
elements in a subperiosteal manner. Alternatively, newer techniques involving minimal incisions exploit the use of specially
designed metal tubes or dilators to gradually separate the posterior soft tissues (muscle fibers) creating an appropriately-sized
tunnel. These less invasive techniques may not only reduce
iatrogenic soft tissue injury, but also decrease post-operative
pain, intraoperative blood loss, and allow for faster recovery, as
compared with traditional open techniques. Unfortunately,
working through small tubes reduces the visual field and may
lead to increased surgical times. Interbody devices and pedicle

screws may all be inserted through these less invasive tube
retractor techniques. Complications specific to the posterior
interbody approach include dural lacerations, epidural fibrosus,
and nerve root injuries.29 Rarely, penetration through the anterior annulus resulting in vascular and visceral injuries has also
been reported.
LUMBAR NUCLEUS PULPOSUS/INTERVERTEBRAL

DISC REPLACEMENT
Lumbar nucleus pulposus and artificial lumbar disc replacement
procedures were introduced to provide pain relief through a stable motion-sparing reconstruction of the intervertebral segment
via tensioning of the annulus fibrosus or stabilization of the
lumbar motion segment. Unfortunately, the extremely large and
complicated forces that exist in the native lumbar intervertebral
disc present a significant engineering challenge in creating an
ideal implant. Presently, several different types of disc prostheses
designed for use in nucleus pulposus replacement or total disc
arthroplasty procedures are either FDA approved or are being
investigated in clinical studies.
The PDN prosthetic disc nucleus, a nucleus replacement device
for symptomatic degenerative disc disease, has met with good success.30 The majority of treated patients reported improved low
back pain and better overall function at two-year follow-up
based on Oswestry and Visual Analog scales. The PDN device
consists of hydrogel core center encased in a high molecular
weight polyethylene sleeve. This device has been shown to shrink
and swell during normal loading and unloading of the lumbar
spine mimicking the healthy human intervertebral disc. It is
hoped that future studies will shed light on the optimum surgical
treatment strategy for symptomatic DDD.
A recent prospective randomized study has demonstrated the
equivalence of an ALIF or total disc arthroplasty in the management of lumbar DDD. In a controlled, prospective, randomized study, 31 60 patients with one-level symptomatic discogenic
lumbar axial back pain were treated with either an ALIF or
an anterior SB Charite artificial disc replacement. The authors
demonstrated comparable improved functional outcome measures
in both treatment groups.
CONCLUSION
The vast majority of patients with LBP either experience complete resolution of their symptoms or require a short period of
non-operative treatment such as anti-inflammatory medication
or physical therapy. However, the most effective method of surgical intervention is still unclear. It may turn out that nucleus
replacement methods suffice for the majority of patients that
present with recalcitrant low back pain allowing for the use of
technically simpler surgery than afforded by performing a total
disc arthroplasty procedure.
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production. Spine 2001; 26:1110-6.
9. Yong-Hing K, Kirkaldy-Willis WH. The pathophysiology of degenerative disease of the lumbar spine. Orthop Clin North Am. 1983 Jul;14(3):491-504.
10. Erkintalo MO, Salminen JJ, Alanen AM, Paajanen HE, Kormano MJ.
Development of degenerative changes in the lumbar intervertebral disc:
results of a prospective MR imaging study in adolescents with and without
low-back pain. Radiology. 1995 Aug;196(2):529-33.
11. Salminen JJ, Erkintalo M, Laine M, Pentti J. Low back pain in the young.
A prospective three-year follow-up study of subjects with and without low
back pain. Spine. 1995 Oct 1;20(19):2101-7; discussion 2108.
12. Savage RA, Whitehouse GH, Roberts N. The relationship between the magnetic resonance imaging appearance of the lumbar spine and low back pain,
age and occupation in males. Eur Spine J. 1997;6(2):106-14.
13. Jensen MC, Brant-Zawadzki MN, Obuchowski N, Modic MT, Malkasian D,
Ross JS. Magnetic resonance imaging of the lumbar spine in people without
back pain. N Engl J Med. 1994 Jul 14;331(2):69-73.
25. Shaffrey CI. Indications for threaded interbody devices. Proceedings of the
16th Annual Meeting of the Federation of Spine Associations. 2001;9.
26. Zdeblick TA, David SM. A prospective comparison of surgical approach for
anterior L4-L5 fusion: laparoscopic versus mini anterior lumbar interbody
fusion. Spine. 2000;25:2682-7.
27. Regan JJ. Laparoscopic lumbar fusion: single surgeon experience in 127 consecutive cases. Proceedings of the 68th Annual Meeting of the American
Academy of Orthopedic Surgeons. 2001;469.
28. Savas PE, Harris BM, Hilibrand AS, et al. Transforaminal lumbar interbody
fusion: the effect of various instrumentation techniques. Proceedings of the
15th Annual Meeting of the North American Spine Society. 2000;216-7.
29. Albert TJ. Complications of cages and dowels. Instructional Course Lecture
#209 of the 68th Annual Meeting of the American Academy of Orthopedic
Surgeons. 2001.
30. Batterjee KA, Ray CD, Osman MA, et al. One year followup on 17 Saudi
patients implanted with a prosthetic disc nucleus. Proceedings of the Annual
Meeting of the International Society for the Study of the Lumbar Spine.
2000;114.
31. McAfee PC, Fedder IL, Saiedy S, Shucosky EM, Cunningham BW. SB Charit
disc replacement: report of 60 prospective randomized cases in a US center. J
Spinal Disord Tech. 2003 Aug;16(4):424-33.
Chapter 2
Nucleus Arthroplasty Motion

Preservation Technology
versus Nucleus Replacement
ASSISTANT PROFESSOR

Baltimore, MD 21204

New York, NY 10021
he purpose of this chapter is to help clinicians understand

the difference between Nucleus Arthroplasty motion preservation technology and nucleus replacement. While the discussion
may seem subjective, the difference between the two terms is vast
and can have a significant impact on a clinical practice.
Nucleus replacement is much like any other joint replacement

within the body. It is meant to replace one biologic component with
another that mimics normal biological function. However, simply
replacing the disc nucleus with a prosthetic device may not address
the problems incurred by patients suffering from degenerative disc
disease (DDD). Unfortunately, DDD is a problem that is not limited
to one portion of the vertebral disc or a single spinal level. Rather,
it is a complex disease that must be
addressed comprehensively.
ARTHROPLASTY MOTION
NUCLEUS
P R E S E R VAT I O N T E C H N O L O G Y G O E S
BEYOND NUCLEUS REPLACEMENT
A N D I N V O LV E S A C O M P R E H E N S I V E
S Y S T E M AT I C A P P R O A C H T O D D D .
10
Nucleus Arthroplasty motion preservation

technology goes beyond nucleus replacement
and involves a comprehensive systematic
approach to DDD. It is not only the implant
that is important in Nucleus Arthroplasty
technology, but the consideration of many factors including proper
patient selection, indications, surgical technique/approach, and
post-operative rehabilitation. Nucleus Arthroplasty technology
involves a complete spectrum of treatment starting with the initial
consultation in the surgeons office and ending with follow-up and
monitoring six months post-surgery. The systematic approach of
Nucleus Arthroplasty technology is better suited to providing predictable and successful outcomes than the device-only approach
of nucleus replacement.
A discussion of the evolution of hip replacement surgery can set

the stage for the discussion of changes currently occurring
in Nucleus Arthroplasty technology. In the 1970s, a degenerated hip joint was treated with a hip replacement device. One
of the biggest problems with early hip replacements was that
the cement used to attach the device to the femur and acetabulum
loosened, resulting in performance problems. The clinical issues
were not simply related to the product but also involved postoperative patient care. These problems were addressed with a
systematic approach to hip replacement. Uncemented hip
replacement devices with a porous coating that allowed bone ingrowth were developed and replaced devices that were cemented
into place. The new generation implant was designed to function
with the patient and was not merely a device within the body. In
addition to improving the implant-to-patient match, specific
post-operative rehabilitation protocols were developed and optimized. The surgeon provided specific and detailed instructions on
when the patient should put weight on the leg and when he or she
should start walking.
Nucleus replacement therapy is currently in an analogous state
to hip replacement surgery in the 1970s. A systematic approach
involving the whole continuum of care is required to achieve
optimum clinical outcomes with Nucleus Arthroplasty technology. Nucleus Arthroplasty system technology is much more
complex than hip replacement given the intricacies of the spine.
It is therefore necessary to address all variables that can affect
the outcome of the treatment. For example, optimal patient
selection and surgical technique without proper rehabilitation
will lead to minimal success. Similarly, thorough post-operative
rehabilitation without appropriate patient selection will also
result in a poor outcome.
While this may seem like common sense, most companies
developing Nucleus Arthroplasty devices have not reached such
a conclusion. Most products are simply nucleus replacement
devices and not arthroplasty systems. Given that each implant
may treat a slightly different indication and require a different
surgical technique means that a unique system involving extensive clinical experience must be developed for each product.
Most disc replacement technologies are not ready for transformation into Nucleus Arthroplasty systems. While companies
can refine their devices, instruments and surgical techniques
through pre-clinical testing, the indications, patient selection
criteria, and post-operative protocol can only be discerned
through actual clinical experience.
Several issues must be addressed in order to advance the field of

Nucleus Arthroplasty motion preservation system. First, the
process of disc degeneration must be better understood. Not all
DDD is the same, just as not all cases of spondylolisthesis and
herniation are the same. Variations in the process of DDD make
it difficult to treat the condition and to achieve predictable outcomes. Second, nucleus replacement devices currently being
developed have crossover indications and applications that make
it difficult for the clinician to determine which device is best
suited for a particular patient at a given stage of the disease
process. Additionally, how a patients DDD is classified can
impact patient selection criteria for Nucleus Arthroplasty therapy.
There is a large difference between what is called mild DDD and
what is called early stage DDD. Some clinicians believe severe
disc collapse must be present before a patient is considered to
be in the early stages of DDD. However, in many cases, a patient
may experience pain for an extended period of time, even
though radiographic evidence of DDD is lacking. These patients
may still be good candidates for Nucleus Arthroplasty nonfusion technology.
THE FUTURE FOR THE NUCLEUS

ARTHROPLASTY MARKET WILL BE MORE
I N D I V I D U A L I Z E D A S T H E Y E A R S G O B Y.
Due to the need to develop specific patient selection and indication criteria for specific devices, the future for the Nucleus
Arthroplasty market will be more individualized as the years
pass. The goal is for a company to have a multitude of device
sizes that can be implanted using a variety of approaches and
implantation techniques. In this way, the implant and surgical
approach can be tailored to address specific patient requirements.
Once again, clinical data is imperative to develop the requisite
patient and product selection criteria. Without valid evidence,
it is more difficult to develop a Nucleus Arthroplasty system that
provides reproducible and successful clinical results. After these
issues are addressed, it is expected that the indications for
Nucleus Arthroplasty systems will be wider than those for total
disc replacements. As more technologies attain long-term clinical
history, the evolution from nucleus replacement to Nucleus
Arthroplasty motion preservation technology will become
clearer to the orthopedic industry, as other arthroplasty
technologies have in the past.
11
Chapter 3
Nucleus Arthroplasty Technology

from the U.S. Regulatory Viewpoint
Glenn A. Stiegman, III, MS

VICE PRESIDENT, REGULATORY AFFAIRS
Musculoskeletal Clinical Regulatory Advisers, LLC

New York, NY 10022
REGULATORY OVERVIEW
t the current time, the Food and Drug Administration (FDA)

considers the term nucleus arthroplasty as broadly applicable
to any device that replaces the nucleus pulposus while preserving the
surrounding annulus. Such devices are intended to reduce pain and
increase function without fusing the spine. The key features of
the FDAs definition include:
Device location (i.e., placement in the nucleus space)
General intent of the device (i.e., not intended to fuse the spine)
Although devices may be varied in their designs, materials, technological characteristics, and implantation methods, any device
that meets the basic criteria outlined above will be regarded by
the FDA as a Nucleus Arthroplasty system.
The regulatory pathway for marketing approval of Nucleus
Arthroplasty devices involves a Premarket Application (PMA)
submission to the FDA. A PMA should establish reasonable
assurance of safety and effectiveness for a novel therapy or
device, typically using valid scientific evidence that is collected in
a well-controlled clinical trial. FDA approval for an Investigational
Device Exemption (IDE) will allow unapproved devices to be
studied in a clinical trial to gather this data. Such trials are
designed to measure patient pain and function at selected time
points following implantation of the Nucleus Arthroplasty device.
This data is most often compared to a control based on the
current standard of care.
12
NUCLEUS ARTHROPLASTY MOTION PRESERVATION TECHNOLOGIES

CURRENT U.S. IDE PILOT STUDIES
TECHNOLOGY
INDICATION
APPROVAL
DATE
1 Spine Wave, Inc.
NuCore
Adjunct To Microdiscectomy
Feb-06
2 Raymedica, LLC
HydraFlex
3 Spine Wave, Inc.
NuCore
COMPANY
4 Disc Dynamics, Inc.

5 Pioneer Surgical Technology
Not Publicly Available
Jun-06
Degenerative Disc Disease
Jun-06
DASCOR
Aug-06
NUBAC
Aug-06
prepared by MCRA, LLC
Currently there are no FDA approved Nucleus Arthroplasty

devices. As of August 2006, four companies are in the process
of conducting five U.S. IDE pilot clinical trials of Nucleus
Arthroplasty technologies.
Although Nucleus Arthroplasty devices may offer many benefits
compared to the current standard of care, device design issues and
clinical concerns must be addressed in order to gather the data
necessary to demonstrate safety and effectiveness. These issues and
concerns should be addressed by means of appropriately-designed
pre-clinical and clinical studies.
also facilitate regulatory negotiations, and will offer the FDA the
opportunity to provide clear feedback during the pre-clinical and
clinical study design stages.
In the face of all these challenges, it is important for the manufacturer to work diligently and consult with the FDA early in the
process to develop appropriate pre-clinical testing. Ideally, this
effort will yield results that are scientifically and clinically relevant,
and that ultimately demonstrate the safety of the device.
REGULATORY REQUIREMENTS
CHALLENGES FOR MANUFACTURERS AND THE FDA
Even in the initial stages of development for new and innovative
therapies, the FDA must require that the preliminary safety of the
device be established prior to starting a human clinical trial. This
represents a formidable obstacle for most device manufacturers
because of limitations in testing and characterization methods.
Often when dealing with novel technologies, industry standards
and FDA guidance documents are not available to provide direction in regard to validation methods. In the case of Nucleus
Arthroplasty devices, the variety of materials, designs, and surgical
implantation techniques have made it virtually impossible to create standardized testing that could be applied to the diversity of
devices. Creating tests that are clinically relevant is also challenging for the device manufacturer. Safety profiles may be very different for each device design; however, testing must be designed
and conducted to demonstrate that devices will not cause unforeseen risks. The devices intended use should direct both pre-clinical and clinical evaluations, including material selection, device
design, pre-clinical testing, surgical technique, and clinical study
design. A clear understanding of the devices intended use will
Regulatory requirements for conducting clinical trials and subsequent PMA applications include extensive preliminary design
validation and pre-clinical studies. The following are some of the
many challenges involved:
Identifying the appropriate patient population
Selecting appropriate device materials
Designing the optimal device and placement technique
Planning and implementing pre-clinical testing
Implementing the clinical trial
PATIENT POPULATION
Paramount to the development of new treatment alternatives is a
clear understanding of the capabilities and success of available
treatment options in contrast to the unmet patient needs. Within
the confines of degenerative disc disease, the potential playing field
seems to be exceptionally large as there is a significant gap between
the conservative and surgical treatment options that are currently
implemented to cover a wide range of indications and potential
degenerative disease stages.
13
In general terms, Nucleus Arthroplasty technologies represent a

host of potential products designed to address degenerative disc
disease. Ideally, the shape, form, and function of each device will
be tailored to meet the individual needs of the patient population
at a specific stage within the degenerative disc cascade.
The success of any Nucleus Arthroplasty device will be directly
tied to the ability of a particular technology to be properly
matched to a defined patient indication. However, trying to
identify the correct patient population and the appropriate time
for surgical intervention are among the biggest clinical challenges facing those who study Nucleus Arthroplasty devices.
From the regulatory perspective, device manufacturers will be
challenged to both define the intended treatment population
and establish evidence of improvement with the proposed
device in relation to the current standard of care.
NUCLEUS ARTHROPLASTY MOTION

P R E S E R VAT I O N D E V I C E S M AY O F F E R
A G O O D A LT E R N AT I V E T O T R E AT
I N D I C AT I O N S W H E R E T H E R E I S N O
R E L I A B L E O R E F F E C T I V E S TA N D A R D
OF CARE.
DEVICE MATERIAL
Determining the appropriate material is one of the key issues
involved in engineering Nucleus Arthroplasty devices, since inappropriate material selection can contribute to potential failure
modes. Each material presents its own regulatory hurdles because
of the lack of validated characterization methods. As material
technologies have advanced, testing standards and characterization methods have remained relatively stagnant. Therefore, older
or non-validated testing methods must be used which may pose
risks to the patient if not performed adequately. While the FDA
can provide valuable feedback about the potential risks and concerns associated with each device, appropriate material characterization activities (i.e., mechanical, animal, and material tests)
must be determined by the manufacturer.
There are several options that can be used to describe and characterize the device material. General biocompatibility evaluation
and testing as recommended in the ISO Standard 10993 is
required and should be performed at the initial stages of material
development. Animal testing is often required to further study the
material. Ideally, animal testing can be performed in a functional
model in which the device is implanted using similar methods to
14
those intended for human use. Establishing a functional model

that appropriately evaluates the device in an animal can be difficult
due to the differences in spinal anatomy and biomechanics
between humans and animals. In such instances where an appropriate functional evaluation cannot be performed, animal testing
may be conducted in which the primary focus is to evaluate the
effects of material particulate in potential worst-case wear debris
conditions. The particulate test usually consists of implanting an
appropriate and clinically relevant wear debris particle quantity,
shape, and size distribution into the spine of a small animal, such
as a rabbit. The intent of this test is to eliminate potential risks
associated with the material.
DEVICE DESIGN
Obviously, the material and design elements of any Nucleus
Arthroplasty device are intimately linked. The broad spectrum
of available materials has resulted in many different Nucleus
Arthroplasty device designs. The challenge is to determine the
best device design for the intended patient treatment population. Each individual design will have specific implications in
regard to indications, patient selection, surgical technique and
post-operative rehabilitation.
Device design performance requirements will also be strongly
influenced by the indications of the selected treatment population. As such, it is critical to completely define the design rationale for the device. This can prove to be a daunting task when
working with Nucleus Arthroplasty technologies as the load environment could be greatly influenced by many factors such as the
EACH INDIVIDUAL DEVICE DESIGN WILL

H A V E S P E C I F I C I M P L I C AT I O N S I N R E G A R D
T O I N D I C AT I O N S , PAT I E N T S E L E C T I O N ,
S U R G I C A L T E C H N I Q U E A N D P O S T- O P E R A T I V E
R E H A B I L I TAT I O N .
level of the disease, bone quality, placement of the device, and

the degenerative disease stage. This situation is further exacerbated by the limited information and clinical experience available to use in defining appropriate design parameters. All of
these factors can affect the clinical results, welfare of the patient,
and ultimately, the success of a particular device.
T H E A B I L I T Y T O U S E T E C H N O L O G I C A L LY A D V A N C E D M AT E R I A L S , D E S I G N
PA R A M E T E R S , S U R G I C A L A P P R O A C H E S , A N D I N S T R U M E N TAT I O N A F F O R D E D
B Y N U C L E U S A R T H R O P L A S T Y M O T I O N P R E S E R VAT I O N T E C H N O L O G Y C A N
M I N I M I Z E T H E R I S K S A S S O C I AT E D W I T H I M P L A N TAT I O N .
In addition to assessing the potential mechanical challenges

imposed on the design, all potential factors associated with the
surgical approach and device delivery method must also be scrutinized. The device may have an ideal design based on biomechanical factors, however, the surgical approach, surgical
instruments, and overall surgical procedure may significantly
affect patient outcomes.
PRE-CLINICAL TEST PLANNING

AND IMPLEMENTATION
Preliminary data on Nucleus Arthroplasty devices can be gathered from various studies worldwide. However, most of these
studies have not been long-term, prospectively defined, controlled, randomized, or powered with the sample size required
to make a strong conclusion about the device being studied.
In order to adequately show the device design is safe, potential
failure modes and clinical risks must be described and mitigated.
Mechanical testing is generally used to evaluate device mechanics
under clinically relevant and/or worst-case loads and displacements. The type of test that is required will vary depending on the
particular device design and intent. A complete evaluation of the
device in a biomechanical model such as a cadaver spine is
important to understand the device mechanics and simulated
anatomical performance. Such testing may also provide valuable
information about the device, surgical approach, proposed surgical instruments, and surgical technique. Loading the spine in various scenarios may also provide insight into potential clinical
failure modes. While many of these failure modes can be
addressed mechanically, there may still be instances in which the
device performs perfectly in a simulated setting yet shows significant failures in subsequent patient evaluations. While mechanical
testing has significant value, comparison of the results to a clinically
successful device or scenario is almost impossible.
CLINICAL TRIAL IMPLEMENTATION

After completing the appropriate pre-clinical testing to characterize device materials, validate the design, and gather preliminary safety data, a device manufacturer must provide all this
information to the FDA. These results will be reviewed by the
FDA and used to justify approval of the human clinical trial.
The data collected in the trial will be used to demonstrate the
safety and effectiveness of the therapy in the PMA application.
IDE PILOT
Since Nucleus Arthroplasty devices are still considered a novel
therapy that utilize a wide array of designs, materials, and
implantation techniques, the FDA will likely require a pilot study
to ensure that these parameters have been optimized. This is
especially true in cases when bench testing is not adequate to
characterize device safety. The IDE pilot study, also known as a
feasibility study, is a limited human clinical study designed to
answer specific questions associated with the device or implantation method and to establish the preliminary safety of the device
and surgical technique. The length of a pilot study can vary from
six months to two years and is largely dependent on the questions or concerns that are being addressed. Specific concerns
about device material, mechanics, or biological effects may
require a study of longer duration while concerns associated
with items such as the surgical technique may be relatively short.
As indicated, a pilot study may assist in addressing concerns that
cannot be tested on the bench. For example, published literature
has reported device expulsions with certain Nucleus Arthroplasty
device designs. However, this particular device failure mode did
not occur during bench, biomechanical, or animal testing.
Clearly, additional bench testing in such situations does not
positively contribute to the existing knowledge base. Thus,
small pilot studies are conducted to provide data that cannot
be obtained strictly through pre-clinical testing.
15
PROPER SELECTION OF A CONTROL

G R O U P I S E X T R E M E LY I M P O R TA N T A S
T H E T R E AT M E N T R E S U LT S F O R T H E
CONTROL WILL SERVE AS A BASIS FOR
C O M PA R I S O N I N R E G A R D T O D E V I C E
SAFETY AND EFFECTIVENESS.
IDE PIVOTAL
After the pilot study has been completed and all questions or
concerns regarding device safety have been addressed, the manufacturer must conduct a clinical study comparing the device to a
valid control. The clinical trial design of the pilot study is often
very similar to the IDE pivotal study. As discussed earlier, selecting a control group can prove to be very difficult in the case of
Nucleus Arthroplasty devices. Proper selection of a control group
is extremely important as the treatment results for the control
will serve as a basis for comparison in regard to device safety and
effectiveness. Selection of a control group that does not closely
match the indications and intended patient population will make
it difficult for the FDA and Centers for Medicare and Medicaid
Services (CMS) to determine the clinical meaning behind the
data and how it would translate to the general U.S. population.
As noted above, prior to selecting a control group, it is imperative that the device indications be appropriately defined. The
device indications dictate the process of identifying a proper
control group and directing the design of the pivotal clinical
trial, length of the study, and primary and secondary endpoint
selections. Most Nucleus Arthroplasty devices are indicated for
mild to moderate DDD or instances of acute disc herniation.
Use of Nucleus Arthroplasty devices to address such indications

will require a two-year clinical study. In addition, post-market follow-up for a minimum of five years may also be
requested. Appropriately describing the indications for the
intended patient population may well determine the success of
the study and the device itself.
Lastly, establishing the appropriate study endpoints is very
important, as they provide the foundation for the demonstration
of safety and effectiveness as well as supporting evidence for the
device labeling claims. If a manufacturer chooses to exclude relevant endpoints in order to avoid risks or save money, the trial
results may be inadequate to support safety or effectiveness, and
may greatly weaken the manufacturers ability to make labeling claims regarding the device performance. Therefore, a
complete and thorough study of all potential study parameters
is recommended, including radiographic, economic, and clinical
assessment measurements.
SUMMARY
Nucleus Arthroplasty motion preservation technology has the
potential to be an excellent treatment alternative for patients in
the mild to moderate stages of DDD. Today, this represents a
relatively large unmet opportunity for advancements in patient
care. However, there are still many unanswered questions that
must be addressed before this device technology can be considered
a viable treatment alternative. As more clinical data becomes
available, manufacturers and the FDA will continue to develop
the expertise required to more appropriately design and evaluate
such devices. Until that time, individual devices must be examined
and studied very carefully on a case-by-case basis.
N U C L E U S A R T H R O P L A S T Y M O T I O N P R E S E R VAT I O N T E C H N O L O G Y H A S
T H E P O T E N T I A L T O B E A N E X C E L L E N T T R E AT M E N T A LT E R N AT I V E F O R
P A T I E N T S I N T H E M I L D T O M O D E R A T E S T A G E S O F D D D . T O D A Y, T H I S
R E P R E S E N T S A R E L AT I V E LY L A R G E U N M E T O P P O R T U N I T Y F O R
A D VA N C E M E N T S I N PAT I E N T C A R E .
16
Chapter 4
Fundamentals of Reimbursement
Kelli Hallas
VICE PRESIDENT
Field Reimbursement Services

Emerson Consultants, Inc.
Eden Prairie, MN 55344
THE IMPORTANCE OF REIMBURSEMENT
btaining optimal reimbursement is critical to the adoption

of a new device or technology. Even though a particular
device has received regulatory approval to be marketed, there is
no guarantee that it will be adopted by surgeons if the practice or
hospital cannot obtain reimbursement from third-party payers.
The increasing costs of procedures and devices will make some
surgeons wary of using a product if the prospect of reimbursement is uncertain. However, as the medical device industry continues to invent and innovate, acquiring reimbursement has
become more difficult. Obtaining proper reimbursement for a
new device is imperative if device manufacturers hope to make
an impact on the market. This is particularly true for orthopedic
devices and technologies because payers are responsible for 90%
of orthopedic procedures. Understanding the reimbursement
process is crucial for medical device companies involved in this
market sector.
Companies can make a multitude of mistakes when seeking reimbursement, especially for a groundbreaking treatment such as
Nucleus Arthroplasty technology. Companies may assume that
receiving Food and Drug Administration (FDA) approval will
automatically guarantee reimbursement from payers, but this is
not necessarily the case. A lack of understanding about the clinical
and economic data required to obtain optimal reimbursement can
result in the demise of a Nucleus Arthroplasty company. Therefore,
Nucleus Arthroplasty companies, especially those seeking new or
17
additional codes, must be aware of what government and private

payers require before granting reimbursement for a new device
or technology.
REIMBURSEMENT BASICS
This chapter will review and discuss the basic elements of reimbursement in regard to Nucleus Arthroplasty motion preservation technologies. Most often reimbursement is thought of as a
single entity when in actuality it is composed of the following
three distinct elements:
Coverage
Coding
Payment
Reimbursement is the end result of the interaction of these drivers.
MOST OFTEN REIMBURSEMENT IS

THOUGHT OF AS A SINGLE ENTITY WHEN
IN ACTUALITY IT IS COMPOSED OF THE
FOLLOWING THREE DISTINCT ELEMENTS:
C O V E R A G E , C O D I N G A N D PAY M E N T.
COVERAGE
Coverage refers to a third-party payers decision on whether or
not to pay for a particular procedure, device, therapy, or service
under the health services or benefits that are arranged, provided,
or paid for through a health insurance plan. A coverage determination is based on whether the procedure, device, therapy, or
service in question is considered a medical necessity. To be considered medically necessary, the goods or services should meet
the following requirements/conditions:
Appropriate and necessary for the symptoms, diagnosis, or
treatment of a medical condition;
Meet the standards of good medical practice within the medical community in the service area;
Unbiased regarding convenience to the plan member or plan
provider;
Most appropriate level or supply of service that can safely be
provided; and
Provided for the diagnosis or direct care and treatment of the
medical condition.
Note that all of the conditions must be satisfied for the good or
service to be considered a medical necessity.
18
Coverage can be favorable, unfavorable, or limited in nature. It may

be issued formally within a policy or granted informally on a caseby-case basis. The coverage of Nucleus Arthroplasty technologies
will vary by payer. Whereas some payers may approve the procedure
for coverage on an individual basis, others will consider the procedure investigational or experimental and deny coverage. This
increased scrutiny is typical for emerging treatments and technologies.
Obtaining a positive coverage decision is critical to the success of
any technology. The following criteria are considered by payers
when making coverage decisions:
The technology must have final approval from the appropriate
governmental bodiesthe FDA in the U.S.
Scientific evidence must permit conclusions concerning the
effect of the technology on health outcomes.
The technology must improve the net health outcomes.
The technology must be as beneficial as any currently
established alternatives.
Improvement must be attainable outside of the investigational setting.
Peer-reviewed data published in a U.S. journal must be
available, preferably from a multi-centered, double blind,
controlled study conducted in the U.S.
It should also be noted that, although a product may not be
intended for significant use in the Medicare population (patients
age 65 and older), the coverage policies developed by the Centers
for Medicare and Medicaid Services (CMS) heavily influence the
coverage decisions of private payers. Therefore, it is important
that companies consider the impact the technology will have on
the Medicare population during clinical trial design. The final
coverage decision made by CMS on any technology may greatly
impact the companys overall bottom line sales.
CODING
Coding represents the reimbursement language that payers and
providers use to communicate. Codes explain the why and the
what, and are universally accepted among physicians, hospitals,
and payers. Providers report on procedures by using various types
of codes both during clinical trials and after FDA approval. Codes
are dynamic and may change even if the product or procedure
does not. In the long term, it is critical that companies work
closely with CMS, the American Medical Association (AMA),
and relevant professional societies to ensure the development
of appropriate coding recommendations.
TABLE 1. CODES TO REPORT NUCLEUS ARTHROPLASTY TECHNOLOGIES

CODE TYPE
NUMBER
DESCRIPTION
ICD-9-CM Procedure
(hospital)
84.64
Insertion of partial spinal prosthesis, lumbosacral; includes nuclear replacement device lumbar; partial
artificial disc prosthesis (flexible) lumbar, and replacement.
ICD-9-CM Procedure
(hospital)
84.68
Revision or replacement of artificial disc prosthesis, lumbosacral; removal of (partial or total) spinal
disc prosthesis with synchronous insertion of new (partial or total) spinal disc prosthesis lumbosacral;
repair of previously inserted spinal disc prosthesis, lumbosacral.
CPT-4
(physician)
22899
Unlisted procedure of the spine.
During a clinical trial, a code that accurately describes a procedure or service may not exist, so an unlisted procedure code
will be reported. This is most often the case with breakthrough and emerging technologies. However, if the appropriate governing body (CMS or AMA) feels that an existing code
can accurately describe the investigational procedure, they may
recommend the use of that code during the clinical trial. In
such instances, it is highly recommended that companies communicate with CMS, the AMA, and professional societies, prior
to making any coding recommendations to providers.
Hospitals and physicians use different coding systems (ICD-9CM and CPT-4 codes) to report on their work. Each of these
systems will be described separately along with the codes to
report Nucleus Arthroplasty technologies.
Hospitals use ICD-9-CM procedure codes to describe inpatient
surgical, diagnostic, and therapeutic procedures (admitted >24
hours). ICD-9-CM codes are controlled by CMS. During a clinical trial, requests can be submitted to CMS for the creation or
modification of an ICD-9-CM code to allow for accurate classification of a new procedure. Formal applications are accepted twice
a year. FDA approval is not required to obtain an ICD-9-CM code
for an inpatient procedure.
CPT-4 codes are used by both physicians and hospital outpatient
departments to describe surgical, non-surgical, and diagnostic
procedures. CPT-4 codes are controlled by the AMA. If the AMA
decides that a procedure is closely related to an existing procedure in consumption of resources, it may recommend use of the
existing code to report the procedure. If the procedure is different and distinct from any current coding descriptions, it will recommend use of an unlisted procedure code during the clinical
trial for tracking and reporting purposes. In the case of Nucleus
Arthroplasty technology, the unlisted procedure code is reported
by the surgeon and will encompass all resource utilization to perform the procedure inclusive of the discectomy.
After the clinical trial has been completed, either a professional

society or an external party can file a formal request for either a
new code or modifications to an existing code if the product or
procedure has:
Received FDA approval
Published U.S. peer-reviewed data
Documented widespread use
Support of the professional society
The codes used to report Nucleus Arthroplasty technologies are
listed above in Table 1.
PAYMENT
Payment is determined by contractual terms between healthcare
providers and payers. These arrangements can take different
forms. Examples of hospital payment methodologies include:
Case rate A payment is arranged to cover a specific procedure, technology, or diagnosis.
Discounted fee for service The payment equals the
amount billed less a pre-negotiated discount.
Fee schedule The facility is paid a flat payment for the
patients admission regardless of resources used or length of
stay (DRG) involved.
Per diem The facility is paid a flat rate per day.
Examples of physician payment methodologies include:
Capitation The physician is paid a certain amount per
member per month to cover the costs of care.
Case rate The surgeon has contracted a fixed fee for a specific procedure.
Discounted fee for service The payment equals the
amount billed less a pre-negotiated discount.
Fee schedule The physician receives a pre-determined payment for a particular service.
19
TABLE 2. DRG ASSIGNMENT FOR

NUCLEUS ARTHROPLASTY TECHNOLOGIES
DRG
DESCRIPTION
499
Back and neck procedures, except spinal fusion

with complications.
500
Back and neck procedures, except spinal fusion

without complications.
In the hospital environment, Medicare pays hospitals according

to the DRG (Diagnostic Related Group) methodology. The
DRG system is intended to classify patients into clinically cohesive groups that demonstrate similar patterns of consumption
of hospital resources and length of stay. According to the
Medicare payment system, Nucleus Arthroplasty technology
will be assigned to one of the DRGs listed above in Table 2.
REIMBURSEMENT FOR NEW DEVICES

When a groundbreaking device is substantially more expensive
than devices that are already on the market, companies will
usually seek a new code to receive proper reimbursement.
However, because claims information does not yet exist, many
companies will apply for an add-on payment, which is a temporary provision for new technologies. This additional payment gives hospitals and surgeons in private practices in the
U.S. an incentive to use products that have recently received
FDA approval. In order to receive an add-on payment, the
product must be:
New,
Substantially improved relative to the existing technology,
diagnosis, or treatment, and
Of sufficient cost.
Add-on payments are difficult to obtain and require sufficient
clinical and economic data in order to prove to payers that such
a payment is justified.
THE CURRENT REIMBURSEMENT STATUS OF

NUCLEUS ARTHROPLASTY TECHNOLOGY
It is helpful to consider the status of Nucleus Arthroplasty technology in order to gain a better appreciation of the current
reimbursement environment for this new technology. Nucleus
Arthroplasty motion preservation technologies are continuously
emerging. Unlike other spine procedures, this breakthrough
technology was not recognized by CMS until October 2004. It
was at this time that CMS created a new subcategory of procedure
codes to classify spine disc replacement technologies including
total and partial replacements.
Although codes were created to enable tracking of Nucleus
Arthroplasty procedures, CMS has collected little claims data
specific to this ICD-9-CM code and technology. This is
because, until recently, no nucleus replacement technologies
have received approval to begin an Investigational Device
Exemption (IDE) clinical trial in the U.S. Due to several recent
approvals, patient outcomes impacting coverage decisions can
now be tracked, and economic data can be collected to ensure
appropriate payment.
Ultimately, it is the responsibility of the industry and health care
providers to assist CMS in making critical coverage and reimbursement decisions impacting this technology. Industry must
ensure that economic data is collected and a solid reimbursement strategy is integrated into the early stages of clinical trial
design and product development. Hospitals and physicians must
adhere to coding guidelines set forth to report the procedures.
All activities that take place during the clinical trial phase will
directly impact payer decisions made after FDA approval and will
ultimately affect the economics of this new technology. CMS
requires data to assist payers in making appropriate decisions. To
ensure positive coverage and payment decisions, this data must be
concise, compelling, and show substantial clinical improvement
over the current gold standard. Therefore, design and execution
of a clinical trial can either make or break a technology.
CONCLUSION
The reimbursement landscape for Nucleus Arthroplasty technologies will continue to evolve. Although a hospital procedure
code exists for the technology; coverage, payment, and physician
CPT-4 codes have yet to be determined. In the end, having a
well-designed reimbursement strategy that engages the efforts
of physicians, professional societies, and industry will have a
positive impact on reimbursement for this technology.
20
Chapter 5
Worldwide Orthopedic
and Spine Market
Viscogliosi Bros., LLC
ASSISTANT PROFESSOR
New York, NY 10022

New York, NY 10021
OVERVIEW
ver the past 15 years, internal fixation with spinal implants

has been used at an accelerated rate in spinal fusion procedures. In the last two years, the advent of non-fusion technologies,
including artificial discs, Nucleus Arthroplasty motion preservation technology and dynamic stabilization systems, have cannibalized revenues from traditional fixation and interbody fusion
(IBF) markets. Based on historic data, the orthopedic sector is
trending towards an industry that will be classified by anatomy.
Currently, orthopedics can be divided into four major segments:
Large bone and joint - Hip and knee replacements and
ancillary technologies
Spine - Fusion technologies and now evolving towards
motion preserving technologies
Small bone and joint - From the finger to the shoulder and
from the toe to below the knee joint
Cranio - Maxillo facial
I N T H E L A S T T W O Y E A R S, T H E A D V E N T O F N O N - F U S I O N
TECHNOLOGIES, INCLUDING ARTIFICIAL DISCS, NUCLEUS
A R T H R O P L A S T Y M O T I O N P R E S E R VAT I O N T E C H N O L O G Y A N D
D Y N A M I C S TA B I L I Z AT I O N S Y S T E M S , H AV E C A N N I B A L I Z E D
R E V E N U E S F R O M T R A D I T I O N A L F I X AT I O N A N D I N T E R B O D Y
FUSION (IBF) MARKETS.
21
The chart below shows the 2006 estimated market size of the
orthopedic sector by segment. The large bone & joint and spine
sectors are expected to account for the lions share of revenue with
90% of the market. It is anticipated that the orthopedic sector will
have the single largest impact on the global healthcare industry
over the next decade, generating over $100 billion in revenues
worldwide. Future growth is highly dependent on both innovation
and distribution. We can expect to see consolidation in this sector,
which will create efficiencies in distribution and set the stage for
2006E Musculoskeletal Industry

By Segment
5%
5%
19%
71%
$30.6 Billion
Source: Viscogliosi Bros., LLC, 2006
large-scale multinational companies to focus on the entire musculoskeletal system. These companies will work to develop a multifaceted arsenal of pharmaceutical, biotech, and nanotech solutions.
Ultimately, the orthopedic sector will grow through life-changing,
surgeon-developed inventions, and the adoption, production, and
global distribution of these devices to patients who demand not
only pain relief, but also the restoration of motion.
The worldwide spine market is estimated to be a $5.8 billion
industry in 2006 and is expected to grow an average 15% to 20%
annually. While historically, this market segment has experienced
a 15% annual growth rate, certain niche markets have been
growing as fast as 40% to 100% per year. The spine market in
2006 is 58 times larger than it was in 1990 when revenues totaled
a mere $100 million. Despite this dramatic increase, this market
is poised for significantly greater growth in the near future due
to a variety of reasons including:
22
A philosophical revolution toward non-fusion technologies

The availability of new technologies globally to treat
expanding indications
A trend in spine surgery toward less invasive procedures
A demographic increase in the number of patients with
back pain
A continuation of intense scientific interest in the study of
spine and back pain
The increased awareness of successful treatment methods
and technologies among spine surgeons
The interest of surgeons and patients in long-term outcomes
In the last few years, the international spine market has seen the
introduction of non-fusion technologies, including Nucleus
Arthroplasty motion preservation system, artificial discs, and
dynamic stabilization systems. The goal of these motion preservation technologies is to stabilize the spine yet allow for movement.
Although spinal fusion is a highly documented and proven form
of treatment for many patients, spine surgeons have expressed
significant interest in pain relieving therapies designed to preserve
the natural motion of a given spinal segment while restoring disc
height and stability. Of particular interest are non-fusion therapies
focused on the treatment of patients with mild or moderate disc
conditions. These new motion preserving technologies can be
divided into three broad product categories:
Dynamic stabilization
Nucleus Arthroplasty technology
Total disc replacement (TDR)
It is our belief that these non-fusion technologies are starting to
cannibalize revenues from the traditional fixation and interbody
fusion markets.
U.S. LUMBAR SPINE TREATMENT CONTINUUM

For many years, neurosurgeons and orthopedic spine surgeons
have recognized the limitations of fusion procedures for treating
back pain and have been actively seeking alternatives. While
todays spine market is focused on fusion, we believe this will
change dramatically over the next several years as non-fusion
devices are introduced and proven to be more effective and beneficial for patients. This will significantly affect the industrys
reliance on fusion revenues and will force the current industry
leaders to reevaluate their product portfolios in order to maintain
their market share.
The current U.S. spine care continuum is delineated as follows:

Conservative treatment - The first treatment is commonly
conservative therapy consisting of bed rest, pain medication, and
physiotherapy. If conservative therapy does not result in sufficient
pain relief, surgical procedures are then considered.
Discectomy/laminectomy - This is the most common surgical treatment for ruptured or herniated discs. The procedure is
considered to be less invasive than other treatment options.
However, many surgeons believe discectomy is only a temporary
solution in which the patient will require secondary surgery, particularly in the case of disc herniation resulting from degenerative disc disease (DDD). This type of surgical intervention may
not be a definitive solution as, in many cases, a discectomy
results in temporary pain relief, but unfortunately creates instability within the spinal column, thereby, usually accelerating the
degenerative process.
Total Disc Replacement (TDR) - The rationale for the use
of a total disc replacement device is to remove the entire disc,
which some believe to be the pain generator. This procedure
replaces the removed disc with a mechanical device that to varying degrees mimics the natural disc motions and biomechanics.
TDRs are mainly used to treat patients with severe and advanced
DDD. At this time, TDR manufacturers who have received or are
seeking Food and Drug Administration (FDA) approval are utilizing designs that are mechanical in nature and composed of
materials commonly found in orthopedic devices.
Fusion - Fusion was developed for the treatment of spinal
instability or deformity. It has also been utilized for the surgical
elimination of painful motion, such as the treatment of low back
pain secondary to DDD. This particular indication has been controversial, although there is medically-based evidence of its effectiveness. Fusion is an invasive, traumatic, and expensive procedure
requiring a lengthy recovery time. It is considered the treatment

of last resort and is reserved for patients with significant
intractable pain and/or neurological deficits. The procedure has
seen many improvements throughout the years, however, fusion
procedures have not always resulted in the best clinical outcomes
leaving many patients unsatisfied. Although fusion may not be
the gold standard in the future, it will continue to be used.
There are at least two gaps that can be identified in the current
treatment continuum that motivate surgeons to seek alternative
non-fusion treatment options. The treatment gaps are as follows:
Gap between conservative treatment and discectomy If a patient fails conservative care and his/her condition does not
warrant a discectomy or laminectomy, the patient is left without
effective treatment options. The only option is to continue conservative care until the patients condition worsens and surgical
intervention is required.
Gap between discectomy and total disc replacement - If a
patient is unable to achieve a successful outcome after discectomy,
the patient may be a candidate for TDR. Current TDR solutions represent an endstage non-fusion approach as the technology requires
sacrifice of the native disc and thus may pose significant challenges
should the treatment prove to be ineffective.
As a result, it is expected that the spine treatment continuum
of the future will shift as shown in the accompanying figure.
Future of Spine Surgery
Number of Patients
An estimated 30 million people in the U.S. report back pain

annually. Of this population, approximately 4.5 million people
continue to experience back pain after receiving conservative
treatment such as physical therapy and/or medication. Only a
small segment from this unresolved pain group, approximately
10%, will be prime candidates for more aggressive treatments
such as TDR or spinal fusion. At this time, there is no welldefined treatment scenario for the remaining individuals with
unresolved pain. The situation is frustrating for surgeons who do
not have the therapeutic options to help the large number of
patients suffering from low back pain.
Non-Fusion
Solutions for
Mild to Moderate
Disc Disease
Conservative
Care
Total Disc Replacement Fusion
Severity of Treatment
23
The indications for a nucleus replacement are much broader

than that for a TDR, as the purpose of TDR is to remove the disc
that is generating pain and replace it with a mechanical device
meant to mimic a healthy spinal disc. Nucleus Arthroplasty
motion preservation technology, on the other hand, is designed
to repair the nucleus and alleviate the associated back pain with
a less invasive process than TDR. While replacing the total disc may
be a solution for some people, it is far too aggressive for others.
New treatment options such as Nucleus Arthroplasty technology

can offer several benefits to address unmet patient and surgeon
needs with improved long-term clinical outcomes, less invasive
surgical techniques, shorter recovery times, and the maintenance of movement. These advantages will become even more
pronounced as spinal arthroplasty device technologies advance
and become one of the principal methods of care for spinal
segment degeneration.
Nucleus Arthroplasty technology offers a treatment option for

early stage DDD using less invasive surgical techniques and it is
expected to supercede many other surgical options. The procedure
results in minimal anatomical destruction with many surgical
access options. Nucleus Arthroplasty technology can used be as a
conjunctive treatment with other non-fusion or fusion therapies
or as an adjunctive treatment above or below the treated level.
When combined with other therapies including dynamic posterior
stabilization, TDR, or fusion, Nucleus Arthroplasty technology
can provide anterior and posterior column support and stabilize
abnormal motion while maintaining segmental mobility. The
Nucleus Arthroplasty motion preservation technology market is
expected to grow to an estimated $2.2 billion by the year 2014.
FUTURE OF NUCLEUS ARTHROPLASTY MOTION

PRESERVATION TECHNOLOGY
Growth in Nucleus Arthroplasty technology usage will likely be
driven by demographic changes, increased use by spine specialty
surgeons, and better defined inclusion/exclusion criteria. Given
the treatment gaps and unmet medical needs, there is a greater
necessity for non-fusion treatment options for surgeons. The
following are some of the possible indications for Nucleus
Arthroplasty systems:
Mild or moderate DDD with low back pain
Prophylactic at same level after discectomy or adjacent level
for adjacent level disease
Central herniation
Hybrid (with posterior dynamic systems)
2014 Nucleus Arthroplasty Motion

Preservation Technology Market
$2.5
Billion
$2.0
Laminectomies
$1.5
Conjuctive w/other non-fusion technologies

Early DDD & not appropriate forTDR
$1.0
Failed Conservative Care
$0.5
W/Discectomy
$0.0
2011
2012
Year
2013
~$2.2 Billion by 2014

24
2014
I N T H E N E X T D E C A D E , I T I S E X P E C T E D T H AT S P I N A L A R T H R O P L A S T Y
W I L L B E C O M E T H E P R I N C I PA L M A R K E T F O R S P I N A L C A R E . I T I S A
B R O A D M A R K E T T H AT I S G A I N I N G I N C R E A S I N G S U R G E O N A C C E P TA N C E .
In the next decade, it is expected that spinal arthroplasty will

become the principal market for spinal care. It is a broad market
that is gaining increasing surgeon acceptance. A greater number
of arthroplasty procedures are being performed each year. More
instrumented spine surgeries have been performed during the
past five years than in the preceding ten years. The increasing
numbers will broaden the market for non-fusion technologies
and create the opportunity for surgeons and patients alike to
recognize the benefits of Nucleus Arthroplasty technology.
U.S. CLINICAL EXPERIENCE

The Hospital for Special Surgery (HSS), New York, New York,
performed a retrospective review of contraindications to lumbar
TDR in 2002 to better understand the indications of this technology and possible clinical impact on their practice. The study
can be summarized as follows:
Of 100 consecutive patients, 56 received fusions
- 0/56 eligible for TDR (0%)
44 received decompressive, non-fusion treatments
- 5/44 eligible for TDR under strict IDE criteria (11%)
40% of the total patient population could have received
a disc nucleus replacement
As this study demonstrates, the patient population for Nucleus
Arthroplasty technology could be larger than the patient population
for TDR, because Nucleus Arthroplasty technology addresses a
treatment gap. It broadens the indications by allowing for the
treatment of a patient population that has been ignored by the
current spine treatment continuum.
A subsequent study performed by HSS focusing on indications

and contraindications for Nucleus Arthroplasty devices found
the following:
Of 85 consecutive patients (117 levels) treated surgically
for symptomatic DDD after a minimum of six months of
conservative treatment
- 53 patients with 1 level disease
- 32 patients with 2 level disease
Contraindications included:
- Schmorls nodes
- > 50% collapse of disc space
- Irregular/convex endplates on the MRI
- Large annular defects
- BMI > 30
Overall, 44/117 levels (37.6%) had no radiographic and
clinical contraindications for nucleus replacement
- 15/53 (28.3%) with 1 level disease were eligible
- 11/32 (34.5%) with 2 level disease were eligible at both levels
- 6/32 (18.8%) with 2 level disease were eligible at 1 level
The most recent study corroborates the results of the earlier
study in that approximately 40% of patients surgically treated
for DDD are eligible for Nucleus Arthroplasty procedures.
The second study also demonstrates that Nucleus Arthroplasty
technology can expand the patient population because multiple
treatments can be performed on one patient.
25
T H E M O S T R E C E N T S T U D Y C O R R O B O R AT E S T H E R E S U LT S O F T H E E A R L I E R
S T U D Y I N T H AT A P P R O X I M AT E LY 4 0 % O F PAT I E N T S S U R G I C A L LY T R E AT E D
FOR DDD ARE ELIGIBLE FOR NUCLEUS ARTHROPLASTY PROCEDURES.
IMPACT ON A SURGEONS PRACTICE

The availability of a Nucleus Arthroplasty treatment option in
the U.S. could greatly expand a surgeons practice by providing
the possibility to solve complex problems that were previously
ignored. Nucleus Arthroplasty technology provides the possibility
of higher clinical success for patients because the treatment is
more appropriate to the level of degeneration. Higher clinical
success rates in turn increase the number of referrals to the
surgeon leading to growth in the practice itself.
says, I think there will be a place for both.1 Dr. Hochschuler

says that spine surgeons can use a combination of new technologies. You can put in a new nucleus or new disc and do
dynamic stabilization. You can put in a total disc and also
replace the facet joints. You can put in a new nucleus and
repair the annulus at the same time. So we wont be choosing
just one of these new technologies; there will be combination.
Thats whats so intriguing.1
Although artificial discs have garnered significant market

attention, they are only one of a number of devices that will
transform spine surgery over the next five to ten years. Nucleus
replacement could be a huge treatment expander, says Scott L.
Blumenthal of the Texas Back Institute, because you can intervene much, much earlierwhen the patient first herniates or
ruptures a discin order to obviate a more aggressive or invasive surgery later on. Stephen H. Hochschuler, MD, also of the
Texas Back Institute, agrees. I think there could be a much
larger market for the nucleus than the total disc, because you
can use the nucleus much earlier.1
SUMMARY
Dr. Blumenthal doesnt believe that nucleus replacement will

make disc replacement redundant, because you cant use artificial nuclei for later-stage degenerative problems. Rather, he
1. Cassak D. Texas Back Institute: Spines Technology Laboratory. IN VIVO.

The Business & Medicine Report. May 1, 2005. Windover Information, Inc
26
Although the specific indications for nucleus replacement technologies are still evolving, it can already be seen that they are
much broader than that for TDR. Given that nucleus replacement technologies provide for treatment earlier in the cascade
of disc degeneration, they will expand the patient population.
The procedure is more surgeon and patient friendly, and the
revision strategies are easier and safer.
REFERENCES
Chapter 6
Nucleus Arthroplasty
Technologies
Matthew E. Cunningham, MD, PhD

ORTHOPAEDIC RESIDENT

New York, NY 10021
ASSISTANT PROFESSOR OF ORTHOPEDIC SURGERY

New York, NY 10021
Dr. med. univ. Rudolph Bertagnoli

FOUNDER
Pro-Spine Medical Consulting

Straubing, Germany 94315
Viscogliosi Bros., LLC

New York, NY 10022
INTRODUCTION
ucleus Arthroplasty motion preservation technology represents a novel treatment approach in which the degenerated
nucleus pulposus is replaced via surgical intervention. The goals of
Nucleus Arthroplasty surgery are to preserve the motion and
geometry of the index intervertebral disc while preventing adjacent
segment degeneration. Such technologies will prove to be of great
appeal when considering the unique clinical challenges associated
with the management of degenerative disc disease (DDD) in
young active patients. If the condition is inadequately treated with
conservative care, progression is predictable. Definitive treatment
with fusion surgery is similarly problematic.
One of the most evident signs of increasing interest in Nucleus
Arthroplasty technology is the involvement of several major spine
companies in the development of Nucleus Arthroplasty devices.
The marketing resources of these industry leaders will serve to
increase general awareness of disc Nucleus Arthroplasty technology
as a successful treatment option and increase the number of
surgeons trained in these technologies.
27
D I S C N U C L E U S A R T H R O P L A S T Y D E V I C E S D AT E B A C K T O T H E 1 9 8 0 S
W H E N C H A R L E S D . R A Y, M D , F A C S C O N C E P T U A L I Z E D A T W O - P I L L O W
HYDROGEL NUCLEUS ARTHROPLASTY DEVICE.
THE HISTORY OF NUCLEUS

ARTHROPLASTY DEVICES
Disc Nucleus Arthroplasty devices date back to the 1980s when
Charles D. Ray, MD, FACS conceptualized a two-pillow hydrogel
Nucleus Arthroplasty device. The original Raymedica PDN
device was completed in 1995, and the first human implant
occurred in 1996. Dr. Rays original design has since been
replaced by single-pillow designs, the Raymedica PDN-SOLO
and HydraFlex devices.
The Stryker Howmedica Osteonics Aquarelle is another example of an early disc Nucleus Arthroplasty device. Qi-Bin
Chip Bao and Hansen Yuan, MD, worked on this device,
which was made of polyvinyl alcohol (PVA), another hydrogelbased technology. The technology was tested in both animal
and biomechanical studies. However, it is believed that this
product is not currently available commercially due to adverse
events encountered in preliminary studies.
CURRENT NUCLEUS ARTHROPLASTY DEVICES

More than 20 different Nucleus Arthroplasty devices are currently in the concept or development stage. These devices use
hydrogel, polymer/synthetic, or mechanical technologies.
Devices using these technologies are as follows:
Hydrogels
PDN-SOLO and HydraFlex devices Raymedica, LLC
NeuDisc Replication Medical, Inc.
Gelifex family of hydrogels Synthes, Inc.
Polymers/Synthetics
DASCOR Disc Dynamics, Inc.
NuCore Injectable Nucleus Device Spine Wave, Inc.
SINUX ANR Sinitec, AG/DePuy Spine, Inc.
BioDisc CryoLife, Inc.
Mechanical
EBI Regain Biomet, Inc.
NUBAC Pioneer Surgical Technology
Each of these technologies and/or devices will be discussed in
some detail in the following sections.
HYDROGEL TECHNOLOGIES
The majority of preformed Nucleus Arthroplasty devices feature
soft hydrogel cores that provide flexibility and absorb/release
water gradually (disc breathing). The implants are designed to
exhibit the weight-bearing characteristics seen in the natural
nucleus and maintain disc space height and mobility in the
intervertebral segment.
Early Drawing of Nucleus Arthroplasty Device by Charles D. Ray, MD, FACS
28
PDN-SOLO AND HYDRAFLEX RAYMEDICA, LLC

Raymedica pioneered the field of Nucleus Arthroplasty motion
preservation systems and is the first company to widely promote
physiological restoration of the form and function of the disc
nucleus. The company was founded in 1990 by Charles D. Ray,
MD, FACS.
The current design of the Raymedica family of Nucleus

Arthroplasty devices features a pellet-shaped hydrogel core
enclosed within a constraining jacket composed of woven, high
molecular weight polyethylene. The constraining jacket is flexible,
yet inelastic and porous allowing fluid to pass through to the
hydrogel core while maintaining the shape memory of the device.
After implantation, the hydrogel core immediately begins to
absorb fluid and expand within the disc space. This design emulates the natural human disc nucleus, which responds to physiological loading by expanding or compressing to provide the
necessary support for the spinal segment. Raymedicas technology
also incorporates the use of platinum-iridium wire markers
embedded in the hydrogel core. The wires allow radiographic
visualization of the device during and after the procedure.
The company has utilized this proprietary preformed hydrogel
technology to develop a range of devices with varying size,
shape, and axial load strength/stiffness characteristics to meet
the needs of individual patient anatomies.
Raymedicas technology is currently utilized in two
product platforms:
PDN-SOLO The PDN-SOLO device is a single-unit
implant designed to replace the diseased nucleus and restore
disc height. The PDN-SOLO device can be implanted via a
posterior PDN approach (PPA) or an AnteroLateral
transPsoatic Approach (ALPA). PPA allows direct decompression with access to the disc space via laminotomy.
ALPA provides direct lateral access to the disc space with no disruption of the posterior elements. The PDN-SOLO device
exhibits outstanding flexibility allowing delivery through either
anatomic approach. The device also provides conformability to
adapt to the human intervertebral disc space.
HydraFlex Nucleus Arthroplasty System This
fourth generation technology is Raymedicas latest system
designed to replace the diseased nucleus and maintain disc
height. The HydraFlex is implanted via an Anterior lateral
RetroPeritoneal Approach (ARPA). This approach permits
control of the annular incision and is less destabilizing to
the index segment compared to the traditional posterior
approach. The HydraFlex device is designed with the same
proprietary preformed hydrogel technology that has been
implanted for more than 10 years. However, this device has
distinctly different design features compared to the PDNSOLO device. The HydraFlex NAS features a more anatomic
contoured shape for a greater fit and fill, a softer core with a
larger footprint to reduce the risk of subsidence, and faster
hydration for quicker stabilization. The HydraFlex NAS also
incorporates specially designed instrumentation to facilitate
repeatable/reproducible intradiscal sizing and precise implant
placement to improve clinical performance.
Neither the PDN-SOLO device nor the HydraFlex NAS are commercially available in the U.S. All non-fusion spinal implants,
including Raymedicas devices, are considered Class III medical
devices and require Pre-Market Approval (PMA) from the Food
and Drug Administration (FDA) prior to market release in the
U.S. Raymedicas goal is to achieve PMA approval for the
HydraFlex NAS, the fourth generation PDN implant, by 2011. It
is Raymedicas belief that the HydraFlex NAS will be one of the
first Nucleus Arthroplasty devices to achieve PMA approval from
the FDA if this goal is met. The company received conditional
FDA approval in June 2006 to begin enrolling patients in a U.S.
feasibility study to evaluate the potential benefits of the
HydraFlex NAS for the treatment of DDD.
Raymedica, LLC is a privately held company headquartered in
Minneapolis, Minnesota. The company currently has CE Mark
approval for the PDN-SOLO and HydraFlex devices and is marketing the PDN-SOLO device in 11 countries. Raymedica is the
pioneer and leader in Nucleus Arthroplasty motion preservation
technology as a result of the extensive clinical experience gained
from over 4,600 implants worldwide since 1996.
29
NEUDISC REPLICATION MEDICAL, INC.

Replication Medical, Inc. (RMI) was formed in 2000 to develop and
commercialize the companys proprietary hydrogel implant technology. The companys sole initial focus is the development of the
NeuDisc spinal nucleus implant. The NeuDisc device is designed to
replace the native nucleus pulposus and restore function to the disc,
potentially slowing or reversing the degenerative process.
THE NEUDISC DEVICE IS DESIGNED TO

R E P L A C E T H E N AT I V E N U C L E U S P U L P O S U S
AND RESTORE FUNCTION TO THE DISC.
The NeuDisc implant, containing H-PAN hydrogel, is delivered

in a semi-hydrated state, intended to allow implantation through
a smaller nucleotomy incision and consequently decreasing the
chances of device migration. Due to the way the H-PAN is layered in the implant, it rehydrates anisotropically within the disc
space meaning that it expands preferentially in the axial direction. A jacket is not required due to the internal structure of the
devices featuring a series of polymer layers tied together with an
internal substructure. The tethering prevents the material from
deforming and creeping. This is an important feature, because
the goal of an implant is to fill the space of nucleus pulposus
completely without changing its diameter after implantation.
A significant amount of mechanical and pre-clinical testing has
been performed on the NeuDisc including compression to failure,
fatigue, cadaver, motion, and biocompatibility testing. The majority of tests have been performed in the U.S., though the NeuDisc
is not commercially available in the U.S. and is currently being
implanted in fewer than 10 centers in the European market.
GELIFEX FAMILY OF HYDROGELS SYNTHES, INC.
The company is developing a spinal nucleus implant

(NeuDisc Radially Anisotropic Spinal Nucleus Implant)
device made of modified polyacrylonitrile polymer, hydrolyzed
to yield a hydrophilic biocompatible polymer gel. The unique
feature of this material is that it can take up 90% of its weight
in aqueous solutions, which is similar to the water content of
nucleus pulposus. When the device is subjected to large loads, it
dehydrates and its stiffness increases. Thus, it responds to loads
in a manner similar to that of nucleus pulposus. The NeuDisc is
inserted in a dehydrated state, facilitating minimally invasive
implantation, and then expands anisotropically after insertion
due to water absorption. The implant is manufactured from a
synthetic polymer, a multiblock acrylic copolymer produced by
partial hydrolysis of polyacrylonitrile.
30
Synthes, Inc. is developing two polymer-based hydrogels as

minimally invasive injectable nucleus replacement technologies
after acquiring Gelifex, Inc. in April 2004. The Gelifex SP and
Gelifex IP hydrogels are liquid at room temperature and solidify inside the core of the disc at body temperature. Anthony
Lowman, PhD, who developed the technology at Drexel
University, describes the material as having the properties of a
porous rubber ball. When the material is introduced to water,
the pores fill to restore the natural height of the disc segment.
Synthes is also working on a second-generation product. This
hydrogel is also liquid at room temperature and designed to
solidify inside the disc space at body temperature. The product
will be delivered via a very small needle through an incision
that will not damage the annulus. Currently, the technology is
not commercially available and is undergoing pre-clinical testing. Pre-clinical biomechanical testing on cadavers was completed in 2003 and preliminary results show that the hydrogel
holds up well matching the properties of the intact spine.
POLYMER/SYNTHETIC TECHNOLOGIES
The concept behind injectable devices using polymer/synthetic
technologies is to deliver the nucleus replacement implant in a
semi-liquid state that then solidifies within the disc space.
Substrates used to date are flexible hydrogels including silk-protein
polymers, serum albumin polymers, and polyurethanes. It is
hypothesized that the ability to deliver the device through a smaller
annulotomy and achieve a unique or perfect fit within the disc
space will reduce the risk for device migration. The goals for the
injectable devices are the same as the preformed devices, namely
preservation of both disc space height and segmental motion.
DASCOR DISC ARTHROPLASTY SYSTEM

DISC DYNAMICS, INC.
The original concept for the DASCOR system was derived from the
Advanced Bio-Surfaces knee surgery research program encompassing extensive in vivo and in vitro studies designed to demonstrate
the biocompatibility and mechanical properties of an in situ curable polyurethane polymer technology. Disc Dynamics, Inc., a private company headquartered in Eden Prairie, MN, was founded in
May 2000 as a spin-off of Advanced Bio-Surfaces with the goal of
developing and commercializing curable polymer technology for
applications in the spine.
The delivery method for the DASCOR system is based on technology used in interventional cardiology. The DASCOR device
is delivered using a catheter and balloon approach under controlled pressure via an injection pump and cures in situ. The system is designed to minimize the incidence of migration, because
the polyurethane polymer is delivered under pressure and completely fills the void left by the removal of the nuclear material.
The polyurethane used in the implant has demonstrated
mechanical strength and durability, while maintaining a low
modulus. It is the belief of Disc Dynamics that the polyurethane
polymer is an ideal biomaterial for disc replacement due to its
well-established biocompatibility profile, superior mechanical
strength, and elastic properties. The material makes it possible to
use a delivery balloon that is robust but compliant with the ability to expand during polymer injection, fill, and conform to the
individual patients nucleus cavity while distracting the disc
space and maintaining disc height. Thus, the technology creates
an individualized solution for each patient.
THE DASCOR DEVICE IS DELIVERED USING

A C AT H E T E R A N D B A L L O O N A P P R O A C H
UNDER CONTROLLED PRESSURE VIA AN
INJECTION PUMP AND CURES IN SITU.
The device is implanted through a very small (5 mm) hole in the

annulus. The size of the required annulotomy incision is significantly smaller than that demanded by other devices and should
reduce the risk of implant extrusion. Although, the risk for extrusion is lower, the device, as with all nucleus replacement devices,
clearly requires the presence of a relatively healthy annulus, as
determined by pre-operative discography.
DASCOR has been in clinical use outside the U.S. since 2003 but
is not commercially available in the U.S. Disc Dynamics received
CE Mark approval for the commercial sale of the technology in
the European Union in July 2005. In August 2006, the company
announced it received FDA approval to start a pilot clinical
study of the DASCOR device.
31
N U C O R E I S A N I N J E C TA B L E P R O T E I N - B A S E D N U C L E U S R E P L A C E M E N T T E C H N O L O G Y
F O R M U L AT E D O N P R O P R I E TA R Y T I S S U E A D H E S I V E T E C H N O L O G Y.
NUCORE INJECTABLE NUCLEUS DEVICE

SPINE WAVE, INC.
NuCore is an injectable protein-based nucleus replacement technology formulated on proprietary tissue adhesive technology.
The NuCore material is comprised of a binary formula of a
chemical cross-linker and a protein co-polymer solution that
cures rapidly in situ forming a durable, adhesive hydrogel
when injected into the disc nucleus space. When cured, the
injected material has been shown to be very resistant to extrusion events seen in other nuclear devices in extensive pre-clinical bench and animal testing. This is primarily the result of
two factors: First, the bolus of cured NuCore material is much
larger than the surgical entry site, thus forming a mechanical
barrier. Second, the hydrogels adhesive properties contribute
to its ability to resist extrusion.
The surgical technique used with NuCore involves mixing the
binary liquid of the silk elastin polymer with the chemical crosslinking agent just prior to injecting them in a minimally invasive
fashion through a syringe. The injected material fills the void left
when nuclear material is removed during discectomy. The liquid
polymer cures rapidly in situ forming a tough, adhesive material.
T H E N U C O R E M AT E R I A L I S C O M P R I S E D O F A
BINARY FORMULA OF A CHEMICAL CROSS-LINKER
A N D A P R O T E I N C O - P O LY M E R S O L U T I O N T H AT
C U R E S R A P I D LY I N S I T U F O R M I N G A D U R A B L E ,
ADHESIVE HYDROGEL WHEN INJECTED INTO
T H E D I S C N U C L E U S S PA C E .
32
Spine Wave, Inc. was created in April 2001 to develop the NuCore
technology. Animal studies and pre-clinical testing has been conducted, though NuCore is not commercially available in the U.S.
In February 2006, Spine Wave announced it was beginning patient
enrollment in a feasibility IDE clinical trial studying NuCore as
an adjunct following a standard microdiscectomy procedure to
fill the void created after herniated nuclear material is surgically
removed. In June 2006, the company announced it was beginning
patient enrollment in a second arm of the feasibility IDE clinical
trial studying NuCore for the treatment of DDD.
SINUX ANR SINITEC, AG/DEPUY SPINE, INC.

The SINUX ANR is a liquid polymethylsiloxane (PMSO) polymer that is injected into the disc with enough pressure to completely fill the void left after removal of nuclear material. The
polymer cures in situ into a resilient elastic mass in approximately 15 minutes without a constraining jacket. The procedure
is minimally invasive and can be performed with a standard discectomy approach. Following implantation of the device, the
annulus is sutured. The SINUX ANR was developed as a nucleus
replacement technology to treat degenerated discs in the lumbar
spine and is commercially available in Europe under the CE
mark obtained in January 2004.
Jan Zoellner, MD, of the Orthopdische Klinik in Johannes
Gutenberg, Germany invented the SINUX ANR technology after
witnessing the high rate of post-discectomy syndrome and failed
back syndrome resulting from the use of rigid systems. Sinitec,
AG, a German-based company that was founded in 1999, signed
an exclusive distribution agreement with Depuy Spine in 2003.
The SINUX ANR device was shown first shown by Depuy Spine
at the Eurospine Conference in Prague in August 2003.
BIODISC INTERVERTEBRAL DISC REPAIR SYSTEM

CRYOLIFE, INC.
The BioDisc system is designed for implantation after the disc
nucleus is removed. Upon injection into the nuclear cavity, the
substance solidifies to form a spacer that provides disc space
distraction, while acting as a glue to bind the vertebral bodies.
The material composition of the BioDisc system is a CryoLife
proprietary product resulting from the in vivo mixture of a protein
solution (serum albumin) and a cross-linking component
(gluteraldehyde). The two solutions are kept in separate chambers
prior to exposure inside the

wall of the annulus and mix
as liquids in vivo forming
a polymerized matrix. The
hydrogel solidifies as a pliable
support solid within the disc
space. The BioDisc material
is similar to epoxy glue and
is composed of the same
base material used in CryoLifes BioGlue surgical adhesive.
However, the formulation for the BioDisc differs from that of
the BioGlue to address use in spinal applications.
The BioDisc material is injected in liquid form from a two-chamber cartridge, which is stored at room temperature. It is believed
that the procedure can be performed percutaneously, where the
product is injected via a 22-gauge syringe under fluoroscopic control. The substances mix and become 90% solid within 30 seconds
of implantation and solidify completely within two minutes. No
heat is generated from the insertion of the material.
Currently, the technology is not commercially available. The
company has completed Phase I and II pre-clinical animal and
bench testing. Enrollment of patients in the BioDisc spinal disc
repair system study was completed in July 2006. The 10-patient
study being conducted in the United Kingdom is designed to
gather basic safety and performance data. The study targets
patients with disc herniations in the lumbar spine at the L4/L5
and L5/S1 vertebral levels.
CryoLife, Inc., founded in 1984, is a life sciences company
involved in the development and commercialization of cryo-preserved and tissue-engineered implantable heart valves, vascular
and orthopedic grafts, and surgical adhesives.
S I N U X A N R I S A L I Q U I D P O LY M E T H Y L S I L O X A N E ( P M S O ) P O LY M E R T H A T I S
I N J E C T E D I N T O T H E D I S C W I T H E N O U G H P R E S S U R E T O C O M P L E T E LY F I L L
T H E V O I D L E F T A F T E R R E M O V A L O F N U C L E A R M AT E R I A L .
33
MECHANICAL TECHNOLOGIES
Preformed implants composed of hard materials including metal
alloys, polyetheretherketone (PEEK), pyrolytic carbon, or zirconia ceramic have been developed. These implants are in contact
with both endplates and transmit forces across the disc space.
REGAIN DISC BIOMET, INC.

The Regain disc is a rigid one-piece device composed of pyrolytic
carbon that is held in the disc space by the natural bony anatomy
of the endplate. The implant geometry is designed to maintain disc
height and to provide for normal motion of the lumbar spine. The
Regain device is highly polished to prevent damage to the cartilage
on the vertebral endplates, and the material has a modulus of elasticity nearly identical to bone. Pyrolytic carbon has a long history
of use in the human body including use in mechanical heart valves
and has not shown biocompatibility issues.
The Regain technology was developed by Biomets EBI division

in conjunction with Steve Cook, MD, of Tulane University.
The accompanying figure shows the implant design used in lumbar nucleus replacement. EBI and Dr. Cook have also developed
a cervical nucleus replacement device.
The Regain device has undergone significant testing and has had
comprehensive bench and cadaver tests. The lumbar device has
been studied in eight baboons and the cervical device has been
studied in 20 dogs. Updates from the 2005 and 2006 Spine
Arthroplasty Society meetings reported no operative complications,
evidence of device migration, neurological compromise, or subsidence after one-year follow-up, although remodeling and sclerosis
were noted. The dog study represents a worst-case scenario for the
technology because the shape of the dogs endplates is opposite that
34
in humans. Currently, the Regain device is not commercially available in the U.S. and is being implanted in limited human clinical
trials in Europe. It is anticipated that Biomet will start a U.S. clinical
trial for the Regain device in September 2006.
Biomet, established in Warsaw, Indiana in 1977, is one of the
worlds largest orthopedic companies with sales of more than
$2 billion annually in more than 100 countries and more than
5,000 employees.
NUBAC PIONEER SURGICAL TECHNOLOGY
The NUBAC disc arthroplasty device is made from PEEKOPTIMA; a material that is currently being commercialized in
spinal fusion implants. NUBAC is the only intradiscal arthroplasty device for patients with degenerative disc disease utilizing
articulating PEEK-on-PEEK material designed to achieve load
sharing and uniform stress distribution under various physiological loading conditions. By providing even stress distribution
with its inner-articulating feature, the NUBAC implant is
designed to minimize potential subsidence and extrusion risks as
well as maintain disc height. The NUBAC procedure is intended
to conserve most of the annular tissue and to be less invasive
than total disc replacement and fusion allowing further treatment options if revision is required. Currently, the technology is
CE marked and being implanted in a limited, controlled fashion
in both Europe and Asia Pacific. NUBAC received conditional
approval from the FDA to proceed with a feasibility study in July
2006, and the first patient was enrolled in August 2006.
Pioneer Surgical Technology, headquartered in Marquette,
Michigan, is a privately held company specializing in the design
and manufacture of spinal and orthopedic implants. The company was founded in 1992 and currently employs over 200
employees worldwide.
Conclusion
ASSISTANT PROFESSOR

Baltimore, MD 21204

New York, NY 10021
lthough much remains to be learned about degenerative

disc disease (DDD), we are on the precipice of a new treatment stratagem for this problem effecting a wide-ranging
patient population which has been inadequately treated with
available treatment options. Nucleus Arthroplasty motion
preservation technology is poised to address mild to moderate
DDD and may be a successful treatment option for later stage
disease as well.
Pioneering spine surgeons have successfully used nucleus replacement to treat DDD. However, Nucleus Arthroplasty technology
takes this promising therapy one step further. Nucleus Arthroplasty
technology is a total system approach that encompasses patient
selection, indications, device sizing, surgical technique and approach,
and post-operative patient care. By adopting this system approach,
Nucleus Arthroplasty technology is expected to offer an effective
treatment option for patients who are currently left untreated.
FUTURE PUBLICATIONS ON NUCLEUS ARTHROPLASTY

MOTION PRESERVATION TECHNOLOGY
We hope this monograph, Book IFundamentals of Nucleus
Arthroplasty Technology, provides valuable guidance to spine
surgeons as they seek to provide more effective and less invasive
options for the treatment of DDD. This book is part of a series
of four books on Nucleus Arthroplasty technology that can be
used individually or collectively. A number of well-known authors
will be represented in future monographs on Nucleus Arthroplasty
technology which will focus on biomechanics, surgical techniques,
and emerging technologies.
The scheduled publication dates are as follows:
Book IIBiomechanics and Development and Book III
Surgical Techniques and Technologies will be available at the
Spine Arthroplasty Society 7 meeting in Berlin, Germany,
May 2007.
Book IVEmerging Technologies is scheduled to be released
at the North American Spine Society meeting in Austin,
Texas, October 2007.
Please note that it is anticipated that electronic versions of this
series will be available approximately one month prior to the
officially scheduled publication date at:
www.nucleusarthroplasty.com
35
Frank P. Cammisa, Jr, MD, FACS

ASSOCIATE PROFESSOR

New York, NY 10021
Justin Eggleton
Contributing Authors
DIRECTOR, SPINE REGULATORY AFFAIRS

New York, NY 10022
Peter Frelinghuysen, MD
FELLOW, SPINAL SURGERY

New York, NY 10021
Rebecca S. Gorman, PA-C

SALES AND MARKETING
Raymedica, LLC
Minneapolis, MN 55431
John J. Grabowski
DIRECTOR, FIELD ENGINEERING
Raymedica, LLC
Polina Hanin
ASSOCIATE, ANALYTICS

New York, NY 10022
David Lown
GENERAL MANGER

New York, NY 10022
Jon R. Luedke
VICE PRESIDENT, SALES AND MARKETING
Raymedica, LLC
O. James May, PA-C

VICE PRESIDENT, TECHNICAL SERVICES
Raymedica, LLC
Ioannis P. Pappou, MD
RESEARCH FELLOW, SPINAL SURGERY

New York, NY 10021
Steven J. Seme, MSME

VICE PRESIDENT, RESEARCH AND DEVELOPMENT/OPERATIONS
Raymedica, LLC
John J. Viscogliosi
CHAIRMAN AND CHIEF EXECUTIVE OFFICER
Raymedica LLC
Robin Young, CFA

EDITOR AND PUBLISHER
Orthopedics This Week

Wayne, Pennsylvania 19087
36
This series has been made possible through the financial support of Raymedica, LLC.

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Nucleus

About the Editors

How the Disc Degenerates

Nucleus Arthroplasty Motion Preservation Technology

Nucleus Arthroplasty Technology from the U.S. Regulatory Viewpoint

Worldwide Orthopedic and Spine Market

Nucleus Arthroplasty Technologies

versus Nucleus Replacement

his monograph series is a groundbreaking project in the

Reginald J. Davis, MD, FACS

Baltimore Neurosurgical Associates, PA

Hospital for Special Surgery

he first documented works describing the diagnosis and

appreciation of pathological processes, such as disc degeneration,

This publication has been constructed to provide an overview

Not to be overlooked, the socioeconomic challenges involved in the

In conclusion, we can say that the spine arthroplasty specialist

Reginald J. Davis, MD, FACS

About the Editors

aymedica has selected Reginald J. Davis, MD, FACS and

on Nucleus Arthroplasty technology, because of their special

widely to speak and train other physicians.

Reginald J. Davis, MD, FACS

Dr. Davis is founder of Baltimore Neurosurgical Associates, chief

Dr. Girardi is assistant attending orthopedic surgeon at the

He has broad experience in advanced procedures such as spinal

How the Disc Degenerates

SPINE RESEARCH FELLOW

Department of Orthopaedic Surgery

Department of Orthopaedic Surgery

RESIDENT ORTHOPAEDIC SURGERY

Department of Orthopaedic Surgery

Department of Orthopaedic Surgery

SPINE RESEARCH FELLOW

Department of Orthopaedic Surgery

Department of Orthopaedics and Neurosurgery

MOLECULAR BIOLOGY OF DISC DEGENERATION

n understanding of the biology of disc degeneration can

THE LUMBAR INTERVERTEBRAL DISC

lamella containing mostly type I collagen arranged in a parallel

occurs, and nutrient uptake and waste elimination occur through

STAGES OF DISC DEGENERATION

The second stage, known as the instability stage, represents more

Stage III (Stabilization)

Stage III (Stabilization)

Stage III: Sagittal MRI demonstrating markedly decreased T2 signal at

presence of DDD.10-15 However, some authors have reported a

INTERBODY STABILIZATION (FUSION) PROCEDURES

INTERBODY FUSION PROCEDURES HAVE BEEN

6. No litigation/workers compensation claims.

Interbody fusion devices or cages come in a variety of shapes and

lead to increased surgical times. Interbody devices and pedicle

LUMBAR NUCLEUS PULPOSUS/INTERVERTEBRAL

24. Zeidman SM. Intradiscal biomechanics: anterior vs. posterior approach-decision

7. Doita M, Kanatani T, Harada T, Mizuno K. Immunohistologic study of the

Nucleus Arthroplasty Motion

Baltimore Neurosurgical Associates, PA

Hospital for Special Surgery

he purpose of this chapter is to help clinicians understand

Nucleus replacement is much like any other joint replacement

Nucleus Arthroplasty motion preservation

A discussion of the evolution of hip replacement surgery can set

Several issues must be addressed in order to advance the field of

THE FUTURE FOR THE NUCLEUS