Data Shows TIF Procedure Controls Subjective Parameters Better Than Maximum Dose PPI Therapy While Achieving Similar Objective Results
SAN MATEO, Calif. (April 22, 2014)–EndoGastric Solutions® (EGS), the leader in endoluminal reconstructive treatment for Gastroesophageal Reflux Disease (GERD), today announced publication of data from its first level-1, randomized, controlled trial directly comparing outcomes from the Transoral Incisionless Fundoplication (TIF®) procedure to maximum-dose proton-pump inhibitor therapy (PPI)—the TEMPO trial. The initial findings showed the TIF procedure was more effective than maximum daily dose PPIs at reducing a wide range of typical and atypical GERD symptoms and in healing of reflux esophagitis while achieving similar normalization rates of distal esophageal acid exposure.
In the TEMPO trial, 97% of patients reported elimination of regurgitation versus 50% in the PPI arm; troublesome heartburn was eliminated in 90% of TIF patients versus 13% of PPI patients. The TIF procedure was better than PPIs in controlling atypical symptoms as indicated by a significant improvement in RSI score (from 23 on PPIs before TIF to 3 off PPIs at 6-month follow-up); in the PPI group the same score fell insignificantly from 23 to 21 on maximum daily-dose of PPIs.
“We believe the TIF procedure fills a therapy gap that exists for GERD patients who take daily PPI therapy and who remain unsatisfied because of incomplete symptom control,” said lead investigator, Karim S. Trad, MD, Clinical Professor of Surgery, George Washington University School of Medicine and Health Sciences. “The TIF procedure may offer these patients the opportunity to safely eliminate their troublesome typical and atypical symptoms without the risk of post-laparoscopic fundoplication syndromes like gas bloat and difficulty swallowing.”
Patients were evaluated using subjective and objective measures including: GERD-HRQL, RSI and RDQ questionnaires, upper endoscopy exams and 48-hr pH monitoring to determine acid levels in the esophagus over two days. Both groups achieved similar normalization of distal esophageal acid exposure (54% of patients in the TIF group and 52% of patients in the PPI group). There was no difference between treatment groups in the clinical characterizations of the disease at baseline.
The results were published OnlineFirst (forthcoming articles published ahead of print) in Surgical Innovation as “Transoral Incisionless Fundoplication Effective in Eliminating GERD Symptoms in Partial Responders to Proton Pump Inhibitor Therapy at 6 months: The TEMPO Randomized Clinical Trial.” The TEMPO data includes six month results from 63 randomized patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices. Similar outcomes were achieved by investigators across specialties, suggesting that the TIF procedure can be performed equally well by both foregut surgeons and gastroenterologists with advanced endoscopic skills.
The TEMPO trial was designed to assess the safety and efficacy of the Transoral Incisionless Fundoplication procedure as compared with high-dose PPI therapy to treat symptoms associated with chronic GERD. Patients will continue in the study until they have completed 3-year follow-up.
Gastroesophageal Reflux Disease (GERD) is a condition caused by anatomical changes where the muscle at the base of the esophagus relaxes between swallows, allowing corrosive stomach acid to wash back up into the esophagus. The stomach produces hydrochloric acid after a meal to aid in the digestion of food. The cells that line the stomach consists of protective mucus that protect it from erosion, but the lining of the esophagus does not share these resistant features and stomach acid can damage it.
GERD is the most common gastrointestinal-related diagnosis given by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 23 million people two or more times per week 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. Over months or years, patients implement these recommendations attempting to manage their symptoms and the quality of their lives becomes negatively impacted.
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. The TIF procedure is a surgical solution that corrects the root cause of Gastroesophageal Reflux Disease (GERD). The TIF procedure is based on traditional surgical principles and offers similar effectiveness to a surgical repair with the safety profile of an incision-free approach. To date, more than 15,000 patients have been treated worldwide. For more information, visit www.GERDHelp.com.
About EndoGastric Solutions®
EndoGastric Solutions, Inc. (www.endogastricsolutions.com), headquartered in San Mateo, California, is a leader in the endoluminal treatment of digestive diseases. EGS’ mission is to combine the most advanced concepts in gastroenterology and surgery to develop products and procedures that address unmet needs in gastrointestinal diseases.
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