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The First Incisionless Transoral Fundoplication for Treatment of Gastroesophageal Reflux is Performed in the U.S. at Ohio State University and Oregon Health & Science University Medical Centers
Date:9/22/2007

EsophyX(TM) receives FDA clearance

REDMOND, Wash., Sept. 21 /PRNewswire/ -- EndoGastric Solutions announces that the EsophyX(TM) device for performing Transoral Incisionless Fundoplication (TIF(TM)) surgery for treating gastroesophageal reflux disease has received FDA clearance. Patients have already been treated at two leading U.S. medical centers in Portland, Oregon and Columbus, Ohio. Three procedures were completed yesterday under general anesthesia, transoral, incisionless, without any external skin incisions or internal dissections and without laparoscopic assistance. These landmark procedures define the launch of the third generation of surgery -- the era of natural orifice surgery (NOS).

Dr. Scott Melvin, Director of the Center for Minimally Invasive Surgery, and Dr. Dean Mikami, Assistant Professor of Surgery, at Ohio State University (OSU), performed the procedures with the EsophyX(TM) device to treat two patients, and Dr. John Hunter, Mackenzie Professor and Chairman of Surgery, and Dr. Blair Jobe, Associate Professor of the Department of Surgery, at Oregon Health & Science University (OHSU), performed a TIF(TM) procedure using the EsophyX(TM) device in one patient, who was originally scheduled for laparoscopic antireflux surgery.

Thierry Thaure, Chief Executive Officer of EndoGastric Solutions, stated, "We are very excited to launch our second product in the U.S. market." StomaphyX(TM) was launched in the U.S. earlier this year. Both products are already on the market in Europe. Before the availability of EsophyX(TM) and StomaphyX(TM), most patients did not have the opportunity to obtain an anatomical repair, because despite the fact that surgery offers a more durable solution to disease, the invasiveness dissuaded many patients and their referring and treating physicians. "These new incisionless procedures expand the therapeutic window." Laparoscopy, performed with three to six trocar holes in the abdomen offer
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SOURCE EndoGastric Solutions, Inc.
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