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Studies Report Use of USGI Medical's Incisionless Operating Platform™ (IOP) in Numerous Incisionless Surgical Procedures
Clinical Data Presented at Society of American Gastroenterological and Endoscopic Surgeons (SAGES) Annual Meeting
SAN CLEMENTE, Calif. (May 4, 2009) - USGI Medical, Inc. (USGI), announced that its Incisionless Operating Platform™ (IOP) was featured in three podium sessions at the 2009 Society of American Gastroenterological and Endoscopic Surgeons (SAGES) Scientific Session & Postgraduate Course, held in Phoenix, Arizona
Dr. Frank Borao and separately Dr. Garth Jacobsen presented on the IOP being used for an incisionless procedure designed to reduce the size of the stomach pouch and opening to the small intestine in patients who developed pouch or stoma dilatation post-Roux en Y gastric bypass (RYGB).
"After reviewing the 12-month images, I believe we demonstrated a durable incisionless revision procedure," said Frank Borao, M.D., FACS, Chief of Minimally Invasive Surgery and Medical Director for the Bariatric Surgery Program of Monmouth Medical Center. Borao's series included 21 patients followed for up to a year.
Dr. Borao reported on his 12-month post-op endoscopies confirming the durability of the procedure: the tissue anchors remained in their original locations, most of the intra-operative stoma and pouch reduction was preserved and durable tissue folds were present. The Monmouth team will continue to follow these patients for up to two years.
"Current procedures to restore the anatomy to the original post-surgery proportions are invasive, and are rarely used due to their complexity and high rate of complications leaving patients without good treatment options," Dr. Borao said. "Given the results of this series, this incisionless procedure has great potential as a safe and durable method for reducing stoma and pouch dilatation post-RYGB, filling a significant unmet medical need in this patient population."
In a third presentation, Santiago Horgan, M.D., Director of Minimally Invasive Surgery at UC San Diego Medical Center and Director of the UC San Diego Center for the Future of Surgery presented data demonstrating the IOP's utility across a number of incisionless procedures and approaches.
"A multifunctional, flexible surgery platform allows the surgeon to choose the preferred surgical approach based on the individual patient's case, which should generate better patient outcomes," Dr. Horgan said. "The vast majority of patients in this study left the hospital within a day and reported minimal pain following the procedures."
Surgical teams at UC San Diego, Legacy Health System in Portland, Oregon and Hospital Bocalandro in Buenos Aires, Argentina used the IOP to perform multiple common surgical procedures using four separate incisionless surgical approaches.
The surgeons used the IOP to perform nine cholecystectomies (gall bladder surgeries), two appendectomies; and 18 endolumenal gastric pouch and stoma reductions in post-Roux-En-Y gastric bypass (RYGB) patients. The cholecystectomy and appendectomy procedures included use of assisting laparoscopic ports with half of these procedures requiring only one. No significant complications were reported in any of the cases.
About the USGI Incisionless Operating Platform™(IOP)
Combining the incisionless nature of endoscopy with the therapeutic benefit of laparoscopy, the IOP offers a stable operating platform, a level view of the operating field and access for multiple, robust, flexible surgical tools - important requirements for Incisionless Surgery. In addition, the IOP can deliver USGI's expandable tissue anchors. These anchors were designed to address the challenges of endolumenal wound closure. The expandable tissue anchors spread forces to allow improved tissue healing and surgical feel while tensioning the sutures.
About USGI Medical, Inc.
Based in San Clemente, Calif., USGI Medical, Inc. develops tools that enable Incisionless Surgery. Incisionless Surgery, which encompasses Natural Orifice Translumenal Endoscopic Surgery (NOTES), endolumenal and single-port techniques, 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. USGI estimates its initial target surgical markets to be around $7 billion in the U.S. Visit us at http://www.usgimedical.com.
Media Contact:
Hollister Hovey
Lazar Partners Ltd.
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