Following the recent authorization by the American drug agency FDA for the marketing of Apollo ESG for the treatment of obesity, comes the publication of the Multi-center Endoscopic Sleeve Gastroplasty (ESG) Randomized Interventional Trial (MERIT) study in The Lancet, which has confirmed the efficacy and safety of the procedure. This was announced by Apollo Endosurgery, world leader in the production of minimally invasive medical devices for gastrointestinal and bariatric interventions, in a note released today.
The growing burden of obesity as a chronic disease requires a multifaceted approach to management. Bariatric surgery is the most successful treatment for obesity. However, many patients avoid surgery due to its perceived invasive nature and fear of complications. Endoscopic Sleeve gastroplasty (ESG) is a less invasive option for thousands of obese patients.
ESG is an incisionless procedure that utilizes an endoscopic suturing system (OverStitch®) to reduce the volume of a person’s stomach and delays emptying of the stomach, resulting in clinically meaningful, durable weight loss. Safety and efficacy were evaluated by the MERIT study, a multi-center, prospective randomized clinical trial which involved 9 US gastroenterology and bariatric surgery centers, among which Mayo Clinic, University of Texas at Houston and Weill Cornell Medicine, and 152 subjects with Body Mass Index (BMI) ≥30 and ≤40 kg/m² for 52 weeks.
Key results for patients undergoing ESG include:
49.2% excess body weight loss at 12 months in the treatment group (vs 3.2% EWL in control)
16.3% average total body weight loss in the responder group
68.3% of responders maintained at least 25% EWL at 104 weeks
Improvements in quality of life, eating behaviors, and depression
Three ESG patients (2.0%) experienced a device or procedure related serious adverse event, all of which resolved and did not require intensive care or surgical intervention.(2)
‘’I have felt for a long-time endoscopic surgery will have a significant impact on the treatment of obesity’’, commented Mr. Jamie Kelly, a leading bariatric surgeon at the Spire Southampton Hospital. An incisionless procedure will help break down the perceived stigma of surgery allowing more patients access to help and improve lives. The FDA grant further supports the ESG as an effective, safe and durable procedure.’’
The full publication of MERIT adds to more than 250 publications and abstracts reporting outcomes in over 10,000 individual patients undergoing ESG procedures. (3)
The Lancet publication follows closely another milestone for Apollo Endosurgery procedures: the FDA De Novo authorization.
The green light from the U.S. regulatory agency covered not only Apollo ESG™ but also Apollo REVISE™, an endoscopic procedure to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
These are the first and only devices authorized by the FDA for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market (4).
‘’The FDA approval for ESG procedure represents a cornerstone. It will open amazing scenarios for untreated obese population seeking for high less invasive procedures and increased quality of life’’ said Dr. Rehan Haidry, Consultant Gastroenterologist and Interventional Endoscopist at University College Hospital, and the Cleveland Clinic London.
Apollo ESG and Apollo REVISE join Apollo’s growing portfolio of endoscopic solutions for weight loss in patients with obesity. The Apollo ESG Systems are intended to be used by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity with Body Mass Index (BMI) between 30-50 kg/m4 who have not been able to lose weight or maintain weight loss through more conservative measures. The Apollo REVISE Systems are intended to be used by trained gastroenterologists or surgeons that perform bariatric procedures to facilitate weight loss in adult patients with obesity with BMI between 30-50 kg/m4 as a revision to a previous bariatric procedure. Studies have shown that after ten years, patients who underwent gastric bypass have regained an average of 20-30% of the weight they initially lost (5).
“The authorization of these new endoscopic systems, together with the publication of Merit Study in such a high impact and influential journal as The Lancet –
said Chas McKhann, President and CEO of Apollo – are a strong testament to the opportunity that we have at Apollo to expand the therapeutic spectrum of obesity and metabolic care to affect real change in the obesity epidemic”.