06.18.14
The American Gastroenterological Association (AGA) Center for GI Innovation and Technology has partnered with EndoGastric Solutions Inc. to develop a registry comparing surgery to an incisionless procedure to treat gastroesophageal reflux disease (GERD).
“EndoGastric Solutions is very enthusiastic to work with the AGA and other stakeholders who have a vested interest in digestive disease. We believe that specialty societies and industry can work together to collect data that inform stakeholders about the effectiveness and durability of medical technology, demonstrate cost-efficiency and value to our health-care system, and ultimately introduce innovation to the health-care market place in a meaningful way ,” said Josh DeFonzo, vice president, EndoGastric Solutions.
The American Gastroenterological Association was founded in 189. Since then, the AGA has grown to include 17,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology.
EndoGastric Solutions develops natural orifice surgical products and procedures to advance the treatment of gastrointestinal diseases. Its products, EsophyX and SerosaFuse fasteners, are designed especially for reconstructive gastrointestinal procedures via transoral approach. The company operates facilities in San Mateo, Calif., and Redmond, Wash.
The “STAR Registry” (Laparoscopic Nissen Fundoplication (LNF) Surgery Versus Transoral Incisionless Fundoplication (TIF): Anti-Reflux Treatment Registry) will provide the first real-world data observing patient outcomes following traditional laparoscopic surgery and TIF with the EsophyX device, according to the AGA.
“Through the STAR Registry, the AGA will bring important data to the conversation about the benefits of surgery in patients with GERD, a condition that affects millions of people,” said M. Brian Fennerty, M.D., A.G.A.F., professor of medicine at Oregon Health Sciences University and principal investigator for the STAR Registry. “This collaboration sets an important precedence for industry and professional societies to work together toward common goals. We will provide physicians, patients, purchasers and payors with additional long-term efficacy data about patients who choose surgical therapy for GERD, which is invaluable to patient care decisions.”
As a neutral objective broker, the AGA Center for GI Innovation and Technology works with device, diagnostic and other life science companies in the gastrointestinal space to identify and gather the data needed by key stakeholders in the health-care system. These stakeholders include providers, payors, purchasers, accountable care organizations and regulatory agencies. The AGA and the center both are working to identify and assess new technologies in patient care and support approval, coverage and adoption of technologies that demonstrate promise and merit.
“GERD is a deceptively complex condition and the most commonly used treatment options may not adequately serve all patients. By collecting data on transoral incisionless vs. laparoscopic fundoplication in a well-designed observational registry, we are able to introduce FDA-cleared innovations to a larger audience, while continuing to evaluate safety, efficacy and comparative outcomes,” said Adrian Lobontiu, M.D., F.A.C.S., medical director at EndoGastric Solutions.
“Every year, tens of thousands of patients with GERD seek consultation about surgical options,” said W. Scott Melvin, M.D., F.A.C.S., vice-chairman and chief of the division of general surgery, Montefiore Medical Center in New York, N.Y.; professor of surgery, Albert Einstein College of Medicine of Yeshiva University (also in New York City); and co-principal investigator for the STAR Registry. “Over the last decade, several technologies that could have improved care for patients with digestive disorders have been limited in application, or eliminated from clinical practice, due to lack of guidance on how to capture and present data demonstrating an improvement in health outcomes.”
The AGA Center for GI Innovation and Technology does not endorse any product or service, develop guidelines, nor make any guarantees about FDA approval or coverage from public or private payors.
EndoGastric Solutions develops natural orifice surgical products and procedures to advance the treatment of gastrointestinal diseases. Its products, EsophyX and SerosaFuse fasteners, are designed especially for reconstructive gastrointestinal procedures via transoral approach. The company operates facilities in San Mateo, Calif., and Redmond, Wash.
