Apollo’s ESG and REVISE Systems approved by FDA
Updated: Aug 1, 2022
Apollo Endosurgery has been granted marketing authorisation for its ESG, ESG Sx, REVISE and REVISE Sx through the FDA’s De Novo Classification process, a rigorous pre-market review pathway for low-to moderate-risk devices without a predicate. According to the company, these are the first and only devices authorised by the FDA for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision.
ESG is an incisionless procedure that utilises an endoscopic suturing system to reduce the volume of a person's stomach and delay emptying of the stomach, resulting in clinically meaningful, durable weight loss. In a randomised controlled trial, the ESG procedure demonstrated safety and effectiveness with durability out to two years.1 The results from this trial add to a larger body of evidence reporting outcomes in over 10,000 patients receiving ESG. ESG can be performed as a same-day procedure without incisions or scars, and patients typically return to work within a few days.
Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.2 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. Transoral outlet reduction (TORe) is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.
Apollo ESG and Apollo REVISE join Apollo's growing portfolio of endoscopic solutions for weight loss in patients with obesity. The Apollo ESG and Apollo ESG Sx Systems are intended to be used by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity with BMI between 30-50 kg/m2 who have not been able to lose weight or maintain weight loss through more conservative measures.
The Apollo REVISE and Apollo REVISE Sx 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/m2 by enabling transoral outlet reduction (TORe) as a revision to a previous bariatric procedure. The systems are used with a dual channel endoscope (Apollo ESG and Apollo REVISE) or single channel endoscope (Apollo ESG Sx and Apollo REVISE Sx).
"The Apollo ESG and Apollo REVISE systems offer a compelling mix of effectiveness, safety, durability and convenience for treatment of patients with obesity," said Chas McKhann, President and CEO of Apollo. "The authorisation of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic."
Abu Dayyeh B, et al. Endoscopic sleeve gastroplasty impact on obesity and comorbidities: results from a US prospective, multicenter, randomized clinical trial with 104 weeks follow-up. Digestive Disease Week; May 24, 2022. Oral presentation.
ASMBS. Estimates of bariatric surgery numbers, 2011-2020.