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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

Saturday, September 22, 2007 General News
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REDMOND, Wash., Sept. 21 EndoGastric Solutions announcesthat the EsophyX(TM) device for performing Transoral IncisionlessFundoplication (TIF(TM)) surgery for treating gastroesophageal reflux diseasehas received FDA clearance. Patients have already been treated at two leadingU.S. medical centers in Portland, Oregon and Columbus, Ohio. Three procedureswere completed yesterday under general anesthesia, transoral, incisionless,without any external skin incisions or internal dissections and withoutlaparoscopic assistance. These landmark procedures define the launch of thethird generation of surgery -- the era of natural orifice surgery (NOS).
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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 twopatients, and Dr. John Hunter, Mackenzie Professor and Chairman of Surgery,and Dr. Blair Jobe, Associate Professor of the Department of Surgery, atOregon Health & Science University (OHSU), performed a TIF(TM) procedure usingthe EsophyX(TM) device in one patient, who was originally scheduled forlaparoscopic antireflux surgery.
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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 arealready on the market in Europe. Before the availability of EsophyX(TM) andStomaphyX(TM), most patients did not have the opportunity to obtain ananatomical repair, because despite the fact that surgery offers a more durablesolution to disease, the invasiveness dissuaded many patients and theirreferring and treating physicians. "These new incisionless procedures expandthe therapeutic window." Laparoscopy, performed with three to six trocar holesin the abdomen offers significant advantage over open surgery, which involvesa long incision on the abdomen, but both are still very invasive. Internalincisions to dissect organs and to perform procedures are similar between opensurgery and laparoscopy. With EsophyX(TM) and StomaphyX(TM), external andinternal incisions have been eliminated.

Dr. John Hunter of Oregon Health & Science University remarked, "I expectEsophyX(TM) to become quite successful because the ELF and TIF(TM) proceduresare based on many years of proven surgical concepts and techniques but withaccess converted to a transoral approach. The EsophyX(TM) procedures lower thehurdle for having surgery and more closely resemble the continuum of care thatis familiar to patients. The TIF(TM) procedure fits nicely betweenpharmaceutical therapy and laparoscopic Nissen fundoplication, and is muchmore than just a replacement for the Laparoscopic Nissen because of thebroader group of patients who can potentially benefit from it."

"There are a staggering number of patients who suffer from reflux withalmost 30 million Americans diagnosed with chronic reflux disease who aredependant on medication," states Dr. Scott Melvin of Ohio State University."EsophyX(TM) offers patients a front line surgical procedure that isincisionless, reversible and repeatable, which is important because it keepsfuture treatment options open. This is a benefit over laparoscopy, and isparticularly important for young patients because reflux is a chronic,progressive disease."

"The EsophyX(TM) device and TIF(TM) procedure have the potential tosignificantly change the treatment algorithm for reflux disease. We are wellon our way to bringing minimally invasive procedures to many patientssuffering from this disease, who currently live their lives from pill-to-pill," states Dr. Stefan Kraemer, Founder and Vice President of ProcedureDevelopment for EndoGastric Solutions. "Surgical know-how and our Europeanexperience have enabled us to fine-tune procedures and training programs.Tha
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