First ROSE procedures with USGI Medical's Incisionless Operating Platform performed in Europe

USGI Medical, Inc., the Incisionless Surgery Company, announced that a surgeon in the U.K. successfully completed Europe's first two scar-free stomach surgery repairs using the company's Incisionless Operating Platform™ (IOP).  Elemental Healthcare Ltd. distributes the IOP in the U.K. market.

Southampton, U.K.-based bariatric surgeon Michael Van den Bossche, MD, FRCS used the IOP to perform ROSE (Repair of Surgery, Endolumenal) on two patients who had started regaining weight after a previous bariatric surgery because their stomach pouches and the opening to the small intestines had stretched in the years since their first operations.

"We're proud to be the first in the UK and Europe to offer the incisionless ROSE procedure," Dr. Van den Bossche said. "There is a significant, growing need for safe, durable, minimally invasive bariatric procedures in patients who've had previous bariatric surgery – or those who are considering it for the first time.  By operating with the IOP through the patient's mouth to create tissue folds in the stomach and secure them with USGI's Expandable Tissue Anchors, we can offer patients a highly discreet outpatient procedure associated with less pain, shorter hospitalization, less risk of infection and no visible scars than traditional surgeries performed through the abdomen."

The procedures were both performed at Spire Southampton Hospital on Thursday, August 19.  ROSE offers patients the first completely incisionless procedure able to revise previous bariatric surgeries such as gastric bypass, sleeve gastrectomy, vertical banded gastroplasty, and gastrogastric fistula.

Roux-en-Y gastric bypass and other bariatric procedures are highly effective, yet up to 40% of patients regain a significant amount of weight a few years after their procedure.  This weight regain can stem from many factors including a dilation of the stomach pouch or the stoma, the opening to the small intestine.  The IOP is used to repair the anatomy.

To perform ROSE, surgeons use the USGI IOP to grasp tissue and deploy the company's specially-designed Expandable Tissue Anchors to create multiple, circumferential tissue folds around the stoma and inside the stomach pouch.  The procedure is performed entirely through the patient's mouth.  An endoscope provides visualization.

Southampton University Hospitals consultant surgeons, James Byrne and Jamie Kelly, together with Mr. Van den Bossche, plan to use similar techniques to perform POSE (Primary Obesity Surgery, Endolumenal) to reduce the size of obese patients' stomachs without external incisions. 

"These first European cases represent a major milestone for USGI and the field of Incisionless Surgery," USGI Medical President and Chief Executive Officer Eugene Chen said.  "A growing number of surgeons have used the IOP to perform hundreds of successful procedures in the U.S. and we look forward to working with our distribution partners to build long-term relationships with sites across Europe so patients there can benefit from Incisionless Surgery.  We expect to have distribution relationships in place in all of the major European markets by 2011."

The USGI IOP combines the flexibility of endoscopy, the surgical capabilities of laparoscopy and a revolutionary new approach to durable wound closure with USGI's Expandable Tissue Anchors.  Surgeons report that the Expandable Tissue Anchors hold stomach tissue in place up to two years.  The IOP remains the first and only Incisionless Surgery platform that can be used across all Incisionless Surgery applications.

USGI believes that this early success in Endolumenal Obesity will lay the groundwork for wider use in a significant number of applications, including single port and NOTES approaches to the most common abdominal procedures performed laparoscopically today.

The devices that make up the IOP have 510(k) clearance in the U.S. and received the European CE Mark in March 2010.

Source USGI Medical, Inc.,

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