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 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.
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.
About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.
Over 22,000 TIF procedures have been performed worldwide. More than 100 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit www.GERDHelp.com.
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.
For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.
About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.
The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.
About EndoGastric Solutions®
Based in Redmond, Washington, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.
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