FDA grants de novo clearance for endoscopic sleeve gastroplasty, bariatric revision devices
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The FDA has granted de novo authorization for Apollo Endosurgery to market its Apollo ESG and Apollo REVISE endoscopic systems for the treatment of patients with obesity, according to a company press release.
These are the first devices authorized by the FDA for endoscopic sleeve gastroplasty and endoscopic bariatric revision procedures.
“Obesity affects 108 million adults in the United States and is growing in prevalence year over year; only a small fraction (approximately 0.2%) are treated with bariatric surgery,” Chas McKhann, president and CEO of Apollo, told Healio. “New medications are more effective than those used in the past, but long-term medical treatment is expensive and patient compliance is challenging. An endoscopic solution for weight loss helps to bridge the large treatment gap by providing people with obesity an option that reduces the volume of the stomach and delivers effective and durable weight loss without incisions or scars.”
Given the explosive growth of the bariatric surgery market — with more than 1.7 million patients having undergone the procedure in the past decade in the U.S. alone — the need for bariatric revision procedures has also increased.
“Bariatric surgery is often very effective, but over time many patients regain weight after surgery,” McKhann said. “Bariatric revision procedures have grown by more than 350% since 2011, according to data tracked by American Society for Metabolic and Bariatric Surgery, and this is the fastest growing segment of the market for traditional bariatric surgeries.”
According to the company press release, the Apollo ESG system is intended for trained gastroenterologists or surgeons to facilitate weight loss among patients with obesity (BMI between 30 kg/m2 to 50 kg/m2) who have either been unable to lose weight or maintain weight loss through more conservative measures. Similarly, the Apollo REVISE system is intended to perform bariatric procedures to facilitate weight loss among adult patients with obesity by enabling transoral outlet reduction as a revision to a previous bariatric procedure.
“These systems allow for a new kind of weight loss procedure,” McKhann said. “They are performed endoscopically, which means that they typically can be performed in a same-day procedure, require minimal time off work and leave no incisions or scars. Some patients are not candidates for surgery or may not be interested in pursuing traditional bariatric surgery but would benefit from weight loss through an endoscopic approach. With endoscopic approaches, we can reach more patients than ever before.”
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