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Endoscopic Suturing Procedure Registry

Apollo and AGA to create endoscopic suturing registry

The Endoscopic Suturing Registry will provide real-world evidence related to the safety and efficacy of a number of flexible endoscopic suturing enabled procedures

Apollo Endosurgery has entered into a Registry Funding Agreement with the American Gastroenterological Association (AGA) Center for GI Innovation and Technology, to develop and administer a registry to evaluate flexible endoscopic procedures enabled by the OverStitch Endoscopic Suturing System.

The Endoscopic Suturing Registry will be managed by the AGA and the two Principal Investigators for the registry will be Drs Jennifer Maranki (Director of Endoscopy at Penn State Milton S Hershey School of Medicine) and Brian Dunkin (Head of Endoscopic Surgery and Medical Director of the Houston Methodist Institute for Technology, Innovation and Education).

The Endoscopic Suturing Registry will provide real-world evidence related to the safety and efficacy of a number of flexible endoscopic suturing enabled procedures, including the revisions of patients after a failed bariatric surgery and the fixation of oesophageal stents to prevent migration, while collecting data usage on other procedures currently in practice.

These procedures are performed using the OverStitch device trans-orally, eliminating risks associated with incisions into the abdomen, thus also having the potential to lower complication rates and reduce total healthcare costs.

The OverStitch endoscopic suturing system enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures from a flexible endoscope. This new technology enables a secure approximation of tissue endoscopically and a wide range of less invasive solutions for physicians who treat defects in both the upper and lower GI tract of their patients. Additionally, physicians are leveraging endoscopic suturing to perform a variety of advanced bariatric procedures.

“Flexible endoscopic suturing is an important tool for the treatment of a number of gastroenterology disorders,” said Dr Michael Kochman, director of the Center for Endoscopic Innovation, Research, and Training, University of Pennsylvania, and past chair, AGA Center for GI Innovation and Technology. “As these procedures become more routine in gastrointestinal and surgery practices across the country, the real-world data AGA will collect through the Endoscopic Suturing Registry will guide all stakeholders in making informed decisions around the continued adoption of these procedures in clinical practice.”

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 healthcare system. These stakeholders include providers, payors, purchasers, accountable care organizations and regulatory agencies. It is the goal of the AGA and its technology centre 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.

“As healthcare plans evaluate the benefits of flexible endoscopic suturing relative to traditional therapies, the Endoscopic Suturing Registry will be an important repository of highly credible clinical data,” said Todd Newton, CEO of Apollo Endosurgery. “Independent real-world data is an important consideration as health plans and payors determine coverage policies for procedures that depend on flexible endoscopic suturing.”

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.

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