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

Main Category: Obesity / Weight Loss / Fitness
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 30 Jun 2009 - 1:00 PDT

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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.

Source: USGI Medical