EndoGastric Solutions Announces 92% Success In Eliminating Daily Drug Dependence In Their European EsophyX ELF Pivotal Trial For GERD

Main Category: Acid Reflux/GERD
Also Included In: GastroIntestinal / Gastroenterology;  Medical Devices;  Clinical Trials / Drug Trials
Article Date: 19 Apr 2007 - 0:00 PDT

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In late 2006, EndoGastric Solutions, the world leader in endoluminal intragastric surgery, completed enrollment in a pivotal trial for the Endoluminal Fundoplication (ELF) procedure treating 84 patients - without incision - using the EsophyX device at seven leading European Medical Centers for purposes of obtaining U.S. FDA clearance. With follow-up completed on 76 of the 84 patients at three months post surgery, 92% of patients were no longer taking daily Proton Pump Inhibitors (PPIs) and 10% were taking only occasional PPIs with an average dosage of less than 30mg per week.

"The EsophyX family of devices are the only systems developed with a thorough understanding of what it takes to surgically create an effective antireflux valve and are built entirely on a flexible transoral platform," said John Hunter, MD, Professor of Oregon Health and Sciences University. "The surgical platform is designed to be iterated quickly and allows the surgeon to customize the repair specifically to the patient's anatomy."

"These two characteristics will allow this field to progress rapidly and, if we continue this pace of progress, we believe we can obtain incisionless reflux control that challenges laparoscopic and open repairs," continued Hunter. "We are very excited about the product, the commitment of EndoGastric Solutions to iterate and evolve, and the scientific and experimental rigor with which this product is being developed."

"This finding of dramatically reduced PPI dependence represents a significant breakthrough for the medical community," stated Professor Guy- Bernard Cadiere, Chief of Surgery of St. Pierre University Hospital in Brussels, Belgium and Co-Primary Study Investigator. "We have been successful in taking our endosurgical valvuloplasty development curve one step further and have improved upon our Phase I results. In addition, we reconfirmed that these valves are stable over the short and medium term which mirrors our experience with the valves created with the laparoscopic Nissen Fundoplication technique."

"The mission of our company is to improve outcomes for patients and offer minimally invasive solutions for treating gastrointestinal diseases," said Susan Gibson, Vice President of Marketing. "Until now, patients with GERD had a choice between a pill-for-life or laparoscopic surgery. Our endoluminal approach is intended to provide patients and their physicians with an option that achieves results similar to Nissen Fundoplication - including reducing or eliminating the need for PPIs - but with less risk and no scarring.

"EsophyX ELF is the first and only device and incisionless procedure designed to reconstruct the GastroEsophageal Valve, addressing the underlying anatomical conditions associated with GERD," continued Gibson. "With millions of people suffering from GERD in the US and Europe, we expect EsophyX to make a significant difference for many patients."

About EndoGastric Solutions, Inc.

EndoGastric Solutions(TM) is a pioneer in endoluminal procedures for the treatment of gastrointestinal diseases, including GERD and obesity. EndoGastric Solutions' mission is to utilize the most current wisdom in gastroenterology and surgery to develop new transoral procedures and products to address the largest unmet needs in gastrointestinal diseases. EndoGastric Solutions technologies involve modifying current open surgical and/or laparoscopic approaches by using transoral access instead of abdominal incisions. The company designs and manufactures single-use instruments that will enable these incisionless solutions, and focuses on clinically based products for use by gastroenterologists and surgeons.

StomaphyX is available in the United States. EsophyX is not available for sale or use in the United States. Both devices are CE marked and available in the European Union.

EndoGastric Solutions, Inc.
http://www.endogastricsolutions.com