IN 5-Y OW

C EA -
FO

LU R U
LL

D
ES
When conservative management

P
fails to tackle the embarrassment
of intrinsic sphincter deficiency

Durasphere
Injectable Bulking Agent

A minimally-invasive treatment
has been designed with patients
and surgeons in mind
DURASPHERE is indicated for the treatment of adult
women with stress urinary incontinence (SUI) due to
INCLUDED IN
intrinsic sphincter deficiency (ISD).
NICE
GUIDANCE
NICE Guidelines in Urinary Incontinence suggest
considering intramural bulking agents, including those of
carbon coated zirconium beads, for the management
of SUI if conservative management has failed1
 Overview Non- Further
Durable References Close
migratory Information

Designed for experts An ideal solution for women with ISD

DURASPHERE Injectable Bulking Agent is composed

of pyrolytic carbon-coated graphite beads suspended
in a water-based carrier gel (2.8% Glucan), conveniently
pre-packed in sterile 3mL syringes.

Durasphere Injectable Bulking Agent

 Overview Non- Further
Durable References Close
migratory Information

Designed for experts An ideal solution for women with ISD

Effective and well-tolerated with an excellent safety profile , Durasphere offers

2 2 2

surgeons a long-term, less-invasive augmentation of the urethra than sling procedures

and artificial sphincters.
Where conventional surgery has not been fully effective
When the patient isnt fit enough for surgery or anaesthesia
When the patient would prefer not to undergo invasive surgery
When the patient has not yet completed her family

Durasphere Injectable Bulking Agent

 Overview Non- Further
Durable References Close
migratory Information

Where does Durasphere fit in?

ISD with ISD with Hypermobility Hypermobility

non-mobile
urethra Mild mobility Significant mobility

Durasphere Durasphere Sling Sling

Candidate Candidate Candidate Candidate

Support is a key factor in the efficacy of a bulking agent.

If the mobility is mild, bulking agents continue to be
a good choice
If the support of the bladder is significantly impaired,
a sling is the best treatment option

Durasphere Injectable Bulking Agent

 Overview Non- Further
Durable References Close
migratory Information

Improved formulation for peace of mind

V E R Proven Pyrolytic carbon has been used for nearly 40 years in

O
, 0 0 0 biocompatibility mechanical heart valves
100 e s , Non-immunogenic No skin test required
c e d u r
p ro i d e3 Small volume Efficacy provided with minimal injected volumes4
l d - w
wor Exceptional delivery The pyrolytic carbon-coated graphite beads are small
performance enough to facilitate ease of injecting, precisely at the desired
location. Syringe delivery offers precision, finger tip pressure
control (unlike gun delivery), that can reduce the likelihood
of delivery system obstruction

Durasphere Injectable Bulking Agent

 Overview Non- Further
Durable References Close
migratory Information

Durasphere stays where its put, with lasting effect

Unlike some bulking agents, pyrolytic carbon-coated

graphite beads cannot be degraded by the body.
Clinical
5-year follow-up shows efficacy is maintained 2 Evidence

 65% of patients (42/65) maintained improvement

in Continence Grade from year 2
 71% of patients (39/55) considered their symptoms
had improved or remained the same by year 5

Durasphere Injectable Bulking Agent

 Overview Non- Further
Durable References Close
migratory Information

Durasphere stays where its put, with lasting effect

Beads are designed with a minimum diameter of 90m

which is 13% larger than the migratory threshold.5

No migration observed at 1 or 2-year follow-up 2,6

N
 o evidence of migration was observed from the patient kidney, urethra,
and bladder X-rays taken at 12 months (n=100) and 24 months post treatment2

Year-1 X-ray* Year-2 X-ray*

*X-rays taken when bead core material was zirconium (prior 2002) and therefore radio-opaque
Durasphere Injectable Bulking Agent
 Overview Non- Further
Durable References Close
migratory Information

References

1. NICE Guidelines, Urinary Incontinence: The management of urinary

incontinence in women (CG171, published September 2013). http://
www.nice.org.uk/guidance/cg171/resources/cg171-urinary-incontinence-
in-women-full-guideline
2. White Paper. Data on File.
3. 100,000 procedures world-wide. Data on File.
4. Lightner D et al. A new Injectable Bulking Agent for Treatment of
Stress Urinary Incontinence: Results of a Multicentre, Randomized,
Controlled, Double-blind Study of Durasphere. Urology 2001; 58:12-15.
5. Malizia AA et al. Migration and granulomatous reaction after
periurethral injection of polytef (Teflon). JAMA 1984; 251:3277-81.
6. Kirkemo A. Independent Expert Radiographic Review of Patients
Treated with Durasphere, Dec 30th 1998.
7. Summary of Safety and Effectiveness Data. Durasphere Injectable
Bulking Agent. United States Food and Drug Administration, July 1999.
8. Expert Testimonials. Data on File.
9. Pad Weight Evaluation. Data on File.
Durasphere Injectable Bulking Agent
 Overview Non- Further
Durable References Close
migratory Information

Your value-added partner in tackling ISD

The advantages offered by June Medical include:

A focus on female pelvic health needs
Effective products with excellent safety profiles
Long term clinical data
High quality training
An experienced team
Excellent customer support
Quality accreditation

Aston Court, Kingsmead Business Park,

Frederick Place,
High Wycombe HP11 1LA
T. 01494 616 505
F. 08721 116 710
E. order@junemedical.com
Back W. junemedical.com

Company Reg no. 08612384

2014 JUNE MEDICAL, all rights reserved.

Date of preparation: October 2014
 Overview Non- Further
Durable References Close
migratory Information

Safety Expert Simple

Product Summary
Profile Opinion Procedure

Durasphere Injectable Bulking Agent

 Durasphere demonstrates an excellent safety profile 7

Safety was measured by the physician through physical examinations, and by questioning patients immediately post-injection, and at
all subsequent follow-ups. All complications or symptoms lasting longer than 24 hours were reported as Adverse Events in the study.

Classification and frequency of ALL events: Mild (87.9%),

Moderate (11.8%), and Severe (0.4%)
Adverse
None of the Severe events were reported as related Events
to the device or the procedure
There were no deaths or unanticipated adverse events
44% of all the mild-moderate adverse events were

deemed to be treatment-related

Back

Durasphere Injectable Bulking Agent

 Durasphere demonstrates an excellent safety profile 7

Safety was measured by the physician through physical examinations, and by questioning patients immediately post-injection, and at
Treatment related adverse events 7
all subsequent follow-ups. All complications or symptoms lasting longer than 24 hours were reported as Adverse Events in the study.
Patients (n) % Patients Events (n)
Acute retention (duration 7 days) 29 16 32
Classification and frequency of ALL events: Mild (87.9%),
Dysuria 22 12 26
Moderate (11.8%), Urinary and Severe (0.4%)
urgency 23 13 25
Urinary tract infection 16 9 18 Adverse
None of the Severe events were reported as Events
Haematuria 11 6 11
related to theNon-acute
device or the procedure
retention (duration >7 days) 10 6 10
Outlet obstruction (slow prolonged
There were no deaths or unanticipated adverse events stream) 8 4 8
Excreted bulking material 7 4 7
 44% of all theGImild-moderate adverse events were 7
(nausea, vomiting, diarrhoea) 4 7
deemed to beGenitourinary (infection, tenderness)
treatment-related 5 3 5
Urinary frequency 4 2 4
Overbulking/abscess/cyst 3 2 3
Infection 1 <1 2
Worsening of incontinence (onset of urge) 1 <1 1
Neurological (headache) 1 <1 1
Pelvic pain 1 <1 1
Allergic reaction to antibiotic 1 <1 1
Fever 1 <1 1
Back

Durasphere Injectable Bulking Agent

 What the experts say:
Durasphere injections have allowed us to provide a
more permanent solution to the incontinence suffered
by our patients with lSD.
- Davila GW, US Urologist8
Durasphere provides my patients with a proven,
reliable, non-immunogenic choice for bulking indications.
It provides a reproducible effect with minimal injected
volumes.
- Dmochowski R, US Urologist18
Back
I have found the durable outcomes from Durasphere
to be better than what I had experienced with other
bulking therapies. I have fewer problems with mucosal
splitting with Durasphere compared to other agents.
Kirkemo A, US Urologist8
Safe, effective, first line treatment for lSD in our
practice - ideal for use in the [outpatient] setting.
- Maccarone JL, US Urologist 8
Durasphere Injectable Bulking Agent
Exceptional delivery performance using periurethral procedure
Periurethral procedure has substantial advantages over transurethral

Easier injection procedure, faster learning curve

No specialized equipment required
Better flow characteristics due to shorter needle
Little to no extravasation due to shorter injection track

A simple procedure to perform which has high

patient satisfaction. The technique is easy to learn.
- Lipsitz DU, US Urologist 8

Durasphere
Injectable Bulking Agent
 With Durasphere, you can clearly see the impact
of the injection during the procedure
View
Video
Clear visualization can be simply achieved using a standard
cytoscope (0 lens) with a urethrotome sheath to prevent
side leakage of cytoscopic fluid (and therefore tissue
collapse) due to the minimal length of the female urethra

Its a 1-procedure learning curve

Back - US Urologist 8

Durasphere
Injectable Bulking Agent
 Available in pre-filled 3mL syringes

No refrigeration required

2 year shelf life

Back

Durasphere
Injectable Bulking Agent
An ideal choice for experts to help improve the lives of patients with ISD
Durable clinical success that surgeons can
see and women can feel
Over 75% of patients improved at 12
months (>50% pad weight reduction) 9
Over 44% of patients (50/113)
became dry at 12 months9
65% of patients (42/65) maintained

clinical improvement at 5 years
follow-up 2
71% of patients (39/55) considered their

symptoms had improved or remained
the same after 5 years2
Durasphere Injectable Bulking Agent
An ideal choice for experts to help improve the lives of patients with ISD
Non-migratory
Bead size above the migratory threshold
5

No evidence of migration was observed

from the patient KUB X-rays taken at 12
and 24 months post treatment 2,6

Durasphere
Injectable Bulking Agent
 An ideal choice for experts to help improve the lives of patients with ISD
Exceptional delivery performance supports ease of use
Optimum bead size and syringe delivery with finger
tip pressure control can reduce the likelihood of
delivery system obstruction
Experts agree that Durasphere is an excellent choice
for women with ISD 8

Back

DurasphereInjectable Bulking Agent

Durasphere shows early success at 1 year 9

In a multicentre, randomized, controlled Over 75% of patients (85/113)

clinical trial, 178 patients were randomized
for treatment with Durasphere and 177 with
improved by >50% at 12 months
collagen between 1996 and 1999. Of these, (pad weight reduction)9
115 Durasphere patients were followed
up for over 12 months. Clinical efficacy Over 44% of patients (50/113)
parameters and the safety profile for the became dry at 12 months 9
injectable bulking agent were evaluated:

Durasphere
Injectable Bulking Agent
Success...that women can feel right from the start
6
 6% (76/115) of patients demonstrated an improvement
of 1 Continence Grade at 12 months 4

Continence Grade Evaluation2

The mean continence grade was significantly improved from 1.86 at
baseline to 0.79 (58% reduction) from the very first month (p<0.001)

2.5

p<0.001 p<0.001 p<0.001 p<0.001

2
Baseline
Mean Grade

1.5
Follow-up

0.5

0
1 Month 3 Month 6 Month 12 Month
(n=115) (n=115) (n=113) (n=115)

Durasphere
Injectable Bulking Agent
Durasphere has a lasting impact
A 5-year post-market study demonstrates long-term effectiveness2

Seventy of the 76 patients improved at the one-year follow up Continence Grade Evaluation
from the original study consented to participate in the post-
approval study and completed a baseline self-assessment at a
65% of patients (42/65) maintained

mean of 2.2 years (1.4 3.5 years) post initial injection. improvement at 5-year follow-up 2

Of these 70 patients, 65 responded to the follow-up self-

assessment at 5.2 years (4.7 6.0 years).

Durasphere
Injectable Bulking Agent
 With significant improvement in quality of life after 5 years
71% of patients (39/55) considered their symptoms

had improved or remained the same by year 52
Nine patients were excluded from this analysis for opting for surgery
to further improve their incontinence.

Back

Durasphere
Injectable Bulking Agent
 With Durasphere, you can clearly see the impact
of the injection during the procedure
View
Video
Clear visualization can be simply achieved using a standard
cytoscope (0 lens) with a urethrotome sheath to prevent
side leakage of cytoscopic fluid (and therefore tissue
collapse) due to the minimal length of the female urethra

Its a 1-procedure learning curve

Back - US Urologist 8

Durasphere
Injectable Bulking Agent