Results from the randomized controlled TEMPO study on GERD patients to be presented Tuesday, May 21st at DDW®
REDWOOD CITY, Calif. (May 14, 2013)– EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for Gastroesophageal Reflux Disease (GERD), today announced the presentation of randomized controlled trial data and key educational activities taking place at Digestive Disease Week® (DDW) 2013, which runs from May 18 to 21, at the Orange County Convention Center in Orlando, Fla.
On Tuesday, May 21st at 10:18 AM results from TEMPO: Transoral Fundoplication vs. Proton Pump Inhibitor (PPI) Therapy for Treatment of Chronic Gastroesophageal Reflux, will be presented during the American Gastroenterological Association’s Late-breaking Clinical Practice, Esophageal, Gastric and Duodenal Disorders, Immunology, Microbiology, and Inflammatory Bowel Diseases, Neurogastroenterology and Motility abstract session in room 303ABC, abstract #925h.
TEMPO principal investigator, Karim S. Trad, MD, Clinical Professor of Surgery, George Washington University School of Medicine and Health Sciences, will present the results and be available at noon in DDW Booth #364 to answer additional questions about the company’s first Level 1, randomized, controlled clinical trial.
“The EsophyX device technology integrates the principles of tried-and-true surgical fundoplication techniques in a minimally invasive endoscopic approach to treat the anatomical defects that cause early GERD,” said Dr. Trad. “This revolutionary, less invasive approach allows us to safely and effectively rebuild the gastroesophageal valve from inside the stomach with an incision-free technique.”
The TEMPO data include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices. TEMPO was designed to assess the safety and efficacy of the Transoral Incisionless Fundoplication (TIF) procedure as compared with high-dose PPI therapy to treat symptoms associated with chronic GERD.
“As a company we could not be more proud about the release of our first Level 1 evidence on the TIF procedure,” said Mike Kleine, President and CEO of EGS. “We are confident that TEMPO will begin to answer important questions about the benefits of the TIF procedure for GERD patients tied to PPI therapy. It will also provide strong clinical evidence to healthcare providers to move GERD patients beyond managing symptoms by referring them to a procedural intervention that repairs failed anatomy.”
TIF Procedure Research and Educational Highlights at DDW:
- Sunday, May 19-Tuesday, May 21: DDW Booth #364 will feature up-to-date data, EsophX device and SerosaFuse® Fastener demonstrations and compelling patient stories
- Saturday, May 18 3:00 – 5:30 PM: “Xtreme Endoscopic Toolbox for 2013” a CME Course accredited by the American Society for Gastrointestinal Endoscopy (ASGE) Hall A2
- Monday, May 20 10:30 AM -12:30 PM: Industry Hands-on Learning Demo hosted by ASGE Hall A2
- Tuesday, May 21 10:00 AM: “Late-Breaking Abstract GI (Clinical)” Room #303ABC
- Tuesday, May 21, Noon: Karim Trad, MD and principal investigator for TEMPO study at DDW Booth #364 to answer additional questions
About EsophyX® and Transoral Incisionless Fundoplication (TIF®)
The EsophyX device was FDA cleared in 2007, and is commercially available in the United States. Inserted transorally with visual guidance from an endoscope, the EsophyX device is used in the TIF procedure to reconstruct the gastroesophageal valve (GEV), restoring its competency and reestablishing the barrier to reflux. TIF is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD), a disease that affects over 60 million people in the U.S. The TIF procedure is based on traditional surgical principles is minimally invasive and offers similar effectiveness to a surgical repair with the safety profile of a transoral approach. To date, more than 10,000 patients have been treated worldwide. For more information, visit www.GERDHelp.com.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in Redwood City, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to utilize the most current wisdom in gastroenterology and surgery to develop procedures and products that address unmet needs in gastrointestinal diseases.
About Digestive Disease Week® (DDW®)
DDW is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, and the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 – 21, 2013, at the Orange County Convention Center, Orlando, FL. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
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