FDA grants de novo clearance for endoscopic sleeve gastroplasty and bariatric revision devices


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The FDA has granted de novo clearance to Apollo Endosurgery to market its Apollo ESG and Apollo REVISE endoscopic systems for the treatment of obese patients, according to a company press release.

They are the first devices cleared by the FDA for endoscopic sleeve gastroplasty and endoscopic bariatric revision procedures.


endoscopy
“Some patients are not surgical candidates or may not be interested in traditional bariatric surgery but would benefit from weight loss through an endoscopic approach,” Chas McKhann, president and CEO of Apollo, told Healio. “With endoscopic approaches, we can reach more patients than ever before.” Source: Adobe Stock

“Obesity affects 108 million adults in the United States and its prevalence is increasing year by year; only a small fraction (about 0.2%) is treated with bariatric surgery,” Chas McKhann, chairman and CEO of Apollo, Healio told Healio. “New drugs are more effective than those used in the past, but long-term medical treatments are expensive and patient compliance is difficult. An endoscopic solution for weight loss helps close the large treatment gap by providing obese people with an option that reduces stomach volume and provides effective, lasting weight loss without incisions or scarring.

Given the explosive growth of the bariatric surgery market – with more than 1.7 million patients having undergone the procedure in the last decade in the United States 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 more than 350% since 2011, according to data tracked by the American Society for Metabolic and Bariatric Surgery, and this is the fastest growing market segment for bariatric surgeries. traditional.”

According to the company’s press release, the Apollo ESG System is intended for gastroenterologists or surgeons trained to facilitate weight loss in obese patients (BMI between 30 kg/m2 at 50 kg/m2) who have 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 in obese adult patients by allowing reduction of transoral outflow as a revision of a previous bariatric procedure.

“These systems allow for a new kind of weight loss procedure,” McKhann said. “They are done endoscopically, which means they can usually be done as a same-day procedure, require minimal downtime, and leave no incisions or scars. Some patients are not candidates to surgery or may not be interested in 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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