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Orbera and Endoscopic Suturing Registry

Orbera study and European Endoscopic Suturing Registry

Orbera post approval study is evaluating the Orbera intragastric balloon and is a multi-centre, open-label, prospective study of the safety and efficacy of the Orberasystem within the US
The objective of this registry is to collect European demographic, procedural and outcome data following the use of the OverStitch Endoscopic Suturing System

Apollo Endosurgery has completed enrolment in the Orbera Post Approval Study evaluating the Orbera intragastric balloon. This is a multi-centre, open-label, prospective study of the safety and efficacy of the Orberasystem within the US. The study was a requirement of the US FDA’s approval of Orberain August of 2015.

The study has enrolled 281 patients across 11 centers. The endpoints include the patient’s percentage of total body weight loss at 26 weeks and 12 months after balloon placement and the rate of adverse events at 26 weeks, the indwell time allowed for the balloon. This study includes 12 months of follow-up after balloon placement: six months with the balloon and an additional six months of follow-up after the balloon’s removal. Patient follow up and final study results are expected in early 2020.

Orbera is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked. During the endoscopic procedure, a thin and deflated Orbera balloon is placed into the stomach. It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the Orbera balloon is deflated and then removed.

Once the balloon is in place, the patient receives an individually tailored support program through the Orbera Managed Weight Loss System team of experts to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals. Coaching takes place over 12 months, even though the balloon is removed after six months. The programme is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.

“The Orberaballoon is the most studied intragastric balloon globally with impressive weight loss and safety results based on its experience in Europe, Latin America and Asia Pacific regions,” said Dr Christopher Gostout, Chief Medical Officer at Apollo Endosurgery. “Reported US clinical results have shown an improvement in both the weight loss and safety data since the initial US pivotal study as US physicians gain experience with patient management. Outcomes consistently exceed criteria identified in guidelines published by our professional societies.”

Apollo has met all the milestones associated with the study and the FDA has assessed the current study status as ‘progress adequate’.

European Endoscopic Suturing Registry

In addition, Apollo and the Istitudo Clinico Humanitas have agreed to establish a multi-centre, 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 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.

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 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 Professor Alessandro Repici.

“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.

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