News & Analysis
News From the Food and Drug Administration
Relief for Central Sleep Apnea
The FDA has approved an implantable de-
vice to help patients with moderate to se-
vere central sleep apnea breathe normally
while they slumber.
Marketed as the Remedē System, the de-
vice consists of a neurostimulator similar to
a cardiac pacemaker. Its transvenous lead
and sensing wires are placed in the upper
chest to stimulate the phrenic nerve and re-
store diaphragm contractions to support
normal breathing during sleep. The system
operates automatically but a physician can
noninvasively change its settings through a
portable tablet programmer.
Unlike obstructive sleep apnea, in which
a partially or completely blocked airway dis-
turbs sleep, central sleep apnea results when
the brain fails to signal the diaphragm via the
phrenic nerve to contract and make room for
air to enter the lungs. Central sleep apnea is
associated with an increased risk of hyper-
tension, myocardial infarction, heart fail-
ure, stroke, obesity, and diabetes, accord-
ing to the FDA. Among patients with chronic
heart failure, an estimated 40% have cen-
tral sleep apnea. Current treatments in-
clude medication, positive airway pressure
devices, or surgery.
In a multicenter trial involving 151
patients, investigators analyzed patients’
outcomes based on the apnea-hypopnea
index (AHI), a measure of how many apnea
or hypopnea episodes occur per hour of
sleep. All patients received the implant. It
was activated in half of the patients; the
other half served as controls. After 6
months, AHI reduction was 50% or greater
in 51% of patients whose device was acti-
vated compared with 11% in the control
group. Adverse events included implant
site infection, swelling, and local tissue
damage or pocket erosion. All patients in
the trial had their devices activated after
the 6-month study period.
Twice the Power in New MRI
A magnetic resonance imaging (MRI)
device with more than twice the static
magnetic field strength as those currently
in use is the first in the country to receive
FDA approval.
1858 JAMA November 21, 2017 Volume 318, Number 19 (Reprinted)
© 2017 American Medical Association. All rights reserved.
Downloaded From: on 11/25/2017
Magnetic resonance imaging scanners
are available in various magnetic field
strengths, which are measured in Tesla (T)
units. The newly approved Magnetom Terra
is a 7T device, compared with the 3T or
lower field strength of scanners used in
medical imaging. Manufactured by Siemens
Medical Solutions Inc, the scanner’s signal-
to-noise ratio is more than double that of
3T scanners, enabling clinicians to see ana-
tomical detail not possible with MRIs hav-
ing lower field strength.
“The added field strength allows for bet-
ter visualization of smaller structures and
subtle pathologies that may improve dis-
ease diagnosis,” Robert Ochs, PhD, director
of the FDA’s Division of Radiological Health,
said in a statement.
Officials at the FDA approved the scan-
ner through its 510(k) pathway, which re-
quires a new device to be “substantially
equivalent” to a predicate device already on
the market. In addition to that equivalence,
the agency’s approval was based on a safety
review of the device’s radiofrequency sub-
system through computational modeling,
simulations, and rigorous experimental mod-
eling. The manufacturer also provided data
from a study that compared images from 35
healthy patients using the 7T device and
a 3T scanner. Board-certified radiologists
who reviewed the images confirmed that
those derived from the 7T were as good
or better than those from the 3T scanner.
According to its manufacturer, some of
the 7T scanner’s advantages include being
able to visualize hippocampal substruc-
tures to aid in evaluating patients with tem-
poral lobe epilepsy or Alzheimer disease,
helping to differentiate between benign and
malignant tumors in the brain, and provid-
ing high-resolution images that may im-
prove diagnoses for orthopedic conditions.
Eye Tracking in Surgical Robotics
Minimally invasive surgery has gotten a
boost with the approval of a new roboti-
cally assisted surgical device.
The Senhance System builds on tradi-
tional laparoscopic surgery with ergonomic
improvements and technological advance-
ments. New eye-sensing technology tracks
surgeons’ pupils so they can pan through-
out the surgical field using only eye move-
ments. Surgeons also can zoom in or out by
moving toward or away from the screen.
Force feedback also helps surgeons feel
whether the tissue they’re grasping with the
robotic arm is stiff or flexible.
TransEnterix Inc of Research Triangle
Park, North Carolina, the device’s manufac-
turer, said in a statement that its product is
the first new entry into the abdominal sur-
gical robotics market since 2000.
Officials at the FDA said the manufac-
turers’ studies of 150 patients under-
going gynecological procedures and 45
who underwent colorectal surgery with
the Senhance System in real-world set-
tings showed that outcomes were compa-
rable with those of other surgical robotics
systems reported in peer-reviewed re-
search articles.
Those data, along with performance
testing results, led FDA officials to conclude
that the new system met criteria for
approval under its 510(k) pathway, which
requires manufacturers to show that their
product is substantially equivalent to
another device already on the market. The
officials said the Senhance System is
Siemens Healthineers
equivalent to the da Vinci Si Surgical Sys-
tem IS3000 for gynecological and colorec-
tal procedures. − Rebecca Voelker, MSJ
Note: Source references are available online
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