Longest follow-up data from randomized controlled trial available
REDMOND, Washington – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced the presentation of three-year follow-up data from TEMPO, a prospective, randomized, multicenter clinical study. The data confirms long-term control of chronic GERD after a Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device. The study will be presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2016 Annual meeting, taking place from March 16-19, 2016 in Boston, Massachusetts.
Sixty-three patients who suffered from troublesome chronic GERD symptoms were randomized to either undergo the TIF procedure (n=40) using the EsophyX device or take proton pump inhibitor (PPI) therapy (n=23); all patients in PPI control group crossed over and received TIF procedures six months after the start of the study.
At up to 36 months follow-up, 91% of patients reported elimination of troublesome regurgitation, 70% were able to completely stop PPI therapy, and reflux esophagitis healed in 87% of patients.
“Our data demonstrates that the benefits of transoral incisionless fundoplication are sustained up to three years following the procedure. Symptom control, reduction in acid exposure, healing of esophagitis, and cessation rates of PPIs are maintained over time, proving that the TIF procedure is a durable alternative to PPIs and more invasive anti-reflux operations” said Karim Trad, MD, Clinical Professor of Surgery at George Washington University School of Medicine and Health Sciences and principal investigator, who will present the data.
The data will be presented the SS08 Flexible Endoscopy session starting at 3:30 PM to 5:30 PM on Thursday, March 17, 2016 in Ballroom A moderated by Frederick L. Greene, MD and G. V. Rao, MS, MAMS.
EGS will also provide demonstrations of the EsophyX device for the TIF procedure at booth #416 in the SAGES exhibit hall from March 16-18.
“The ongoing, excellent results from this multi-center study represent another clinical milestone and add to the existing strong body of clinical evidence that support the TIF procedure as an excellent treatment option for patients who no longer benefit from PPIs and are seeking long-term relief from ongoing GERD symptoms,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Our thanks to Dr. Trad and the other investigators for their ongoing commitment to providing the GERD patients they serve with a full armamentarium of treatment options.”
In 2015 SAGES, in cooperation with the three primary GI societies—AGA, ACG, ASGE, jointly sponsored an application to the American Medical Association for a new Category I Current Procedural Terminology (CPT®) code. CPT 43210: EGD esophagogastric fundoplasty became effective January 1, 2016.
About Current Procedural Terminology (CPT®)
CPT codes are a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients, and third parties. CPT® is registered trademark of the American Medical Association.
The Federal Register has posted coding and payment information specific to the new CPT code, allowing patients to more easily receive access to treatment for GERD. Physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures for TIF procedures as of January 1, 2016.
Gastroesophageal reflux disease (GERD) 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. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.
GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 80 million people at least once per month in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g., diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum-dose usage of prescription medications has been linked to a variety of other health complications.
About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair another treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.
Over 17,000 TIF patients have been treated worldwide since EsophyX® device clearance in 2007. More than 60 peer-review papers from over 50 centers have been published documenting consistent outcomes on over 1100 unique study patients. For more information, visit www.GERDHelp.com.
About EsophyX® technology
The original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z in 2015. The technology has continued to evolve and is a clinically-backed tool for physician use in the treatment of GERD. The EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes–including low profile and larger high-definition models—to treat the underlying anatomical cause of GERD. The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope.
About EndoGastric Solutions®
Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company focused on developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of gastroesophageal reflux disease (GERD). EGS has combined the most advanced concepts in gastroenterology and surgery to develop the Transoral Incisionless Fundoplication (TIF®) procedure—a minimally invasive solution that addresses a significant unmet clinical need.
The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.
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EndoGastric Solutions, Inc.
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Phone: 646-871-8481 (direct)