American Gastroenterological Association and EndoGastric Solutions Establish Registry for GERD Procedures
BETHESDA, Md., March, 20, 2014 /PRNewswire-USNewswire/ -- The American Gastroenterological Association (AGA) Center for GI Innovation and Technology today announced a partnership with EndoGastric Solutions® to develop a registry comparing surgery to an incisionless procedure to treat gastroesophageal reflux disease (GERD).
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.
"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, MD, AGAF, 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 GI 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. It is the goal of the AGA and the center to identify and help assess the value of new technologies on 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, MD, FACS, medical director, EndoGastric Solutions.
"Every year, tens of thousands of patients with GERD seek consultation about surgical options," said W. Scott Melvin, MD, FACS, vice-chairman and chief of the division of general surgery, Montefiore Medical Center; professor of surgery, Albert Einstein College of Medicine of Yeshiva University; 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."
"EndoGastric Solutions is very enthusiastic about the opportunity 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 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.
About the AGA
The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, 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. The AGA Institute administers the practice, research and educational programs of the organization. www.gastro.org
The AGA Center for GI Innovation and Technology supports innovation and the development of new technology in gastroenterology, hepatology, nutrition and obesity by guiding medical device and therapeutics innovators through the technology development and adoption process. www.gastro.org/CGIT
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.
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.
SOURCE American Gastroenterological Association