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Registry will collect demographic, procedural, and outcome data after use of the OverStitch Endoscopic Suturing System.
October 29, 2018
By: Business Wire
Apollo Endosurgery Inc., a global developer of less invasive medical devices for bariatric and gastrointestinal procedures, announced an agreement with Istitudo Clinico Humanitas to establish a multicenter, retrospective, data repository for gastrointestinal applications performed using Apollo’s OverStitch Endoscopic Suturing System. Professor Alessandro Repici, director of the Digestive Endoscopy Unit of Istituto Clinico Humanitas, will serve as the principal investigator. Endoscopic suturing can be used to support a wide variety of therapeutic, gastrointestinal endoscopic procedures. Patients who have previously undergone an endoscopic suturing procedure at a participating center with the OverStitch device will be eligible for inclusion in the registry. The study will initially include six leading gastroenterology centers in five countries in Europe. “The European GI Registry for endoscopic suturing is an amazing opportunity to create a repository of data on Advanced Gastrointestinal Applications coming from some of the most outstanding European centers and will allow an increased understanding of the efficacy, benefits and outcomes associated with endoscopic suturing procedures,” said Repici. The objective of this registry is to collect European demographic, procedural and outcome data following the use of the OverStitch Endoscopic Suturing System. Data will be collected on a variety of applications including closure of full thickness and mucosal defects, post-operative leaks, perforations, fixation of endoprosthetics, treatment of gastrointestinal bleeding, and other procedures. The goal is to support the clinical use and benefits of endolumenal suturing as well as provide real-world data on safety and effectiveness which can support physicians, patients and payers in making informed decisions. “The future for therapeutic endoscopy is very promising, especially with flexible endoscopic suturing utilizing OverStitch. By allowing physicians to suture with precision and assurance of depth, up to full thickness, OverStitch enables many improved therapy options for their patients. These leading centers participating in the registry will be instrumental in generating data for their peers and national health systems across Europe,” said Todd Newton, CEO of Apollo Endosurgery. The registry will start collecting data immediately. 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. Apollo Endosurgery Inc. is a medical technology company focused on less invasive therapies for the treatment of obesity, a condition facing over 650 million people globally, as well as other gastrointestinal conditions. Apollo’s device based therapies are an alternative to invasive surgical procedures, thus lowering complication rates and reducing total healthcare costs. Apollo’s products are offered in over 70 countries today and include the OverStitch Endoscopic Suturing System, the ORBERA Intragastric Balloon, and the LAP-BAND Adjustable Gastric Banding System. Apollo’s common stock is traded on Nasdaq Global Market under the symbol APEN.
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