Apollo Endosurgery Announces American Society for Metabolic and Bariatric Surgery Added Apollo Systems To List Of FDA Approved Bariatric Devices On December 5

Author: Benzinga Newsdesk | December 13, 2022 08:38am

Apollo Endosurgery, Inc. ("Apollo") (NASDAQ:APEN), a global leader in minimally invasive medical devices for gastrointestinal and bariatric procedures, announced today that the MERIT trial, published in The Lancet earlier this year(1), was selected as 2022 Top Story in Gastroenterology.(2) Additionally, the American Society for Metabolic and Bariatric Surgery (ASMBS) formally added four Apollo systems to its list of FDA Approved Bariatric Devices on December 5.(3) These milestones come only months after Apollo received FDA marketing authorization for Apollo ESG, Apollo ESG Sx, Apollo REVISE and Apollo REVISE Sx to facilitate weight loss in patients with obesity (BMI 30-50 kg/m2).

In the Expert Opinion article published in Gastroenterology announcing the selection of the MERIT trial as the 2022 story of the year, Dr. Steven A. Edmundowicz, Past President and Master of the American Society for Gastrointestinal Endoscopy (ASGE), highlighted the outcomes of the MERIT trial, including 77% of the ESG group reaching 25% or more excess weight loss versus 12% in control group, low adverse event rate managed without ICU care or surgery, and 80% of ESG group with improvement in one or more metabolic comorbidity. Dr. Edmundowicz also called for a "unified approach" among gastroenterology and surgical societies to support patients with obesity and in the pursuit of insurance coverage.

The selection of the MERIT trial follows just days after Endoscopic Sleeve Gastroplasty (Apollo ESG™, Apollo ESG Sx™ Endoscopic Suturing System) and Transoral Outlet Reduction (TORe) (Apollo Revise™ and Apollo Revise Sx™ Endoscopic Suturing System) were added to the FDA Approved Bariatric Devices list by ASMBS. ASMBS endorsed procedures and FDA approved medical devices do not require IRB approval in accredited MBSAQIP-Accredited centers. Physicians will now be able to perform these procedures with the FDA authorized devices at MBSAQIP accredited centers without the need for IRB approval; procedures will also be included in the MBSAQIP database.

"Apollo celebrates these important milestones and recognizes the diligence, efforts, and advocacy of many in advancing endobariatrics into the mainstream of care for patients with obesity," commented Chas McKhann, President and CEO of Apollo. "We are grateful for the continued support of both the gastroenterology and bariatric surgery communities in bringing awareness to the issue of obesity and the importance of expanded treatment options for patients."

About the MERIT Study

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