Surgeons Use USGI Medical's Incisionless Operating Platform to Reduce Pouch, Stoma...

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Mon Jun 29, 2009 10:20am EDT

Surgeons Use USGI Medical's Incisionless Operating Platform to Reduce Pouch,
Stoma Size in Gastric Bypass Patients

Results from 116 Patients Presented at American Society of Metabolic and
Bariatric Surgeons (ASMBS) Meeting

Data Show USGI's Expandable Tissue Anchors Remain in Place Up to 12 Months

SAN CLEMENTE, Calif., June 29 /PRNewswire/ -- New data show that surgeons can
use USGI Medical Inc.'s (USGI) Incisionless Operating Platform(TM) (IOP) to
durably reduce the size of the stomach pouch and stoma in Roux-en-Y Gastric
Bypass (RYGB) patients who are regaining weight because this portion of their
anatomy has stretched since their original surgery. 

On Friday, June 26 at the American Society of Metabolic and Bariatric Surgeons
(ASMBS) Annual Meeting near Dallas, University of California, San Diego (UCSD)
Medical Center surgeon Santiago Horgan, M.D. presented outcomes from 116
patients who underwent this incisionless procedure to reduce the size of their
pouch and stoma. 

"We believe this is the first data to confirm 12-month durability for gastric
folds created without incisions," said Dr. Horgan, director of UCSD's Center
for the Future of Surgery and Center for the Treatment of Obesity.  "Invasive
procedures to restore the anatomy to the original post-surgery proportions are
too complicated for many patients.  Surgeons have tried to perform restorative
procedures through the mouth using other types of endoscopic instruments,
however GI tissue is extremely resistant to change and it's been difficult to
show long-term durability of procedures utilizing endoscopic sutures or
staples.  USGI's Expandable Tissue Anchors have allowed us to achieve a
desired amount of durable reduction in the pouch and stoma size without any
significant adverse events, filling a significant unmet medical need in this
patient population."  

To perform a Restorative Obesity Surgery, Endolumenally (ROSE), surgeons used
USGI's IOP to grasp tissue and deploy Expandable Tissue Anchors to create
multiple, circumferential tissue folds around the stoma and inside the pouch.
The procedure is performed entirely through the patient's mouth.  An endoscope
provides visualization.  

Surgeons were able to place tissue folds in 112 of 116 (97%) patients. On
average, surgeons placed six Expandable Tissue Anchor pairs in each of these
112 patients and reduced their mean stoma diameter by 50% and pouch length by
44%.  

Dr. Horgan reported that twelve-month post-op endoscopies performed on 19
patients to date confirmed the durability of the procedure: the tissue anchors
remained and durable tissue folds were present.  There were no significant
complications associated with the procedure and most patients reported no or
minimal pain.

About Incisionless Surgery

Incisionless Surgery is the next wave in minimally invasive surgery and is
rapidly becoming an option demanded by patients, and healthcare providers for
its potential to minimize pain, shorten hospital stays, lower treatment costs
and eliminate visible external scars. Incisionless Surgery, which encompasses
Natural Orifice Translumenal Endoscopic Surgery (NOTES), endolumenal and
single-port techniques, can be applied to bariatric surgery, cholecystectomy,
appendectomy, GERD (Gastroesophageal Reflux Disease), gastrointestinal cancer
and urological and gynecological procedures.

About the USGI Incisionless Operating Platform(TM) (IOP)

USGI Medical designed the Incisionless Operating Platform(TM) (IOP) to enable
Incisionless Surgery.  Combining the flexibility of endoscopy with the
therapeutic benefit of laparoscopy, the IOP offers a stable operating
platform, access for multiple, robust, flexible surgical tools and durable
tissue anchors to predictably approximate and permanently affix tissue --
important requirements for Incisionless Surgery that traditional endoscopes
and endoscopic instruments do not provide.  The IOP incorporates the
TransPort(TM) Operating Platform and instruments for cutting, suturing and
grasping tissue.  The surgeon advances the TransPort into the body in its
flexible state to conform to the patient's anatomy, the surgeon uses an
endscope and various tools though the TransPort's four operating channels to
steer the end of the device to visualize a site, and perform surgery with
control and efficiency.

Media Contact: 

Hollister Hovey (of Lazar Partners Ltd.)
hhovey@lazarpartners.com
646-871-8482


SOURCE  USGI Medical

Hollister Hovey of Lazar Partners Ltd., +1-646-871-8482,
hhovey@lazarpartners.com
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