MEDICAL DEVICE INNOVATION - Medical Device Daily

MEDICAL DEVICE INNOVATION 2010
EndoBarrier’s new Restrictor
spurs even more weight loss
By OMAR FORD
Medical Device Daily Staff Writer
GI Dynamics (Lexington, Massachusetts) said it has
once again struck gold in the fight for weight loss, with a
new component to its EndoBarrier device.
The company reported that patients who have been fitted
with the EndoBarrier Gastrointestinal Liner are seeing
even more excess weight being shed with the addition of
the new EndoBarrier Flow Restrictor to the device.
“With the EndoBarrier just used by itself on a patient,
we see about 20% excess weight loss at six months,”
Jonathan Hartmann, a spokesman for GI Dynamics told
Medical Device Daily from the floors of the International
Federation for the Surgery of Obesity and Metabolic
Disorders annual meeting in Paris. “When we combine the
flow restrictor with the EndoBarrier we see nearly double
the weight loss.”
Hartmann and representatives from GI Dynamics are
set to present results of a clinical study regarding the effectiveness
of EndoBarrier with Flow Restrictor at the conference,
tommorrow.
The study, which was previously highlighted in June at
the 26th annual meeting of the American Society for
Metabolic and Bariatric Surgery (ASMBS; Gainsville
Florida), demonstrated the substantially enhanced weight
loss benefits of combining the company’s EndoBarrier
Gastrointestinal Liner with a new EndoBarrier Flow
Restrictor.
In this initial, single-center study of 10 morbidly obese
people (body mass index between 35.8 and 47.8), participants
achieved the following results over a twelve-week
period during which the device was implanted (median values
reported):
• Percent Excess Weight Loss (%EWL): 39.6%
• Weight Loss: 36.7 pounds (16.7 kilograms)
• Percent Total Body Weight Loss (%TBWL): 15.4%.
All 10 patients completed the 12-week study. The most
common side effects included mild to moderate abdominal
pain, nausea and vomiting.
“We have had significant clinical experience with the
EndoBarrier at our obesity management center, and even
when assessed relative to invasive and other noninvasive
procedures, we believe the EndoBarrier platform represents
a much needed new approach to reducing weight and
improving blood sugar control in obese patients and
patients at risk for serious metabolic disease,” said Manoel
Galvao Neto, MD, a lead investigator for the study.”
“In particular, we are excited about the new data
emerging from our ongoing clinical study in people living
with Type 2 diabetes and the notable impact EndoBarrier
59
appears to have on blood sugar control. We look forward to
sharing these data later this year upon completion of the
trial,” he said.
The EndoBarrier Flow Restrictor provides an adjustable
restriction at the outlet of the stomach and is designed to
delay gastric emptying, an additional mechanism which
adds to the therapeutic effects of the liner.
The EndoBarrier GI Liner, by itself creates a physical
barrier that lines the intestine to keep food from coming in
contact with the intestinal wall. Physicians believe this may
alter the activation of hormonal signals that originate in the
intestine, and may mimic the effects of a Roux-en-Y gastric
bypass procedure.
However, the EndoBarrier procedure is done without
the risks associated with highly invasive surgical procedures.
The EndoBarrier is placed and removed endoscopically
(via the mouth) without the need for surgical intervention
or alteration of the patient’s anatomy.
“It’s the same device, but the flow restrictor has a
diaphragm in the center of it with a 4 mm hole in its center,”
Hartmann said.
So far, clinical trials involving more than 250 patients
have demonstrated the dramatic weight loss and diabetes
improvement achieved with the EndoBarrier
Gastrointestinal Liner.
These latest data suggest that the combination of the
EndoBarrier Gastrointestinal Liner with the EndoBarrier
Flow Restrictor could enhance the effectiveness of the liner
by nearly doubling the amount of weight-loss achieved by
using the liner alone. The clinical data is consistent with
previously reported pre-clinical data from the company
assessing the combination of devices in a porcine model.
(This story originally appeared in the Aug. 28, 2009,
edition of Medical Device Daily)
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