The US Food and Drug Administration (FDA) has cleared for marketing the first devices indicated for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision, according to the manufacturer.
The Apollo ESG, Apollo ESG Sx, Apollo Revise, and Apollo Revise Sx systems made by Apollo Endosurgery Inc, were reviewed through the de novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.
“The Apollo ESG and Apollo Revise systems offer a compelling mix of effectiveness, safety, durability, and convenience for treatment of patients with obesity,” Chas McKhann, president and CEO of the company, says in a news release.
“The authorization of these new endoscopic systems represents a major step forward in addressing the global obesity epidemic,” McKhann adds.
The Apollo ESG and Apollo ESG Sx systems are intended for use by trained gastroenterologists or surgeons to facilitate weight loss in adults with obesity who have failed to lose weight or maintain weight loss through more conservative measures, the company says.
The Apollo Revise and Apollo Revise Sx systems allow gastroenterologists or surgeons to perform transoral outlet reduction (TORe) as a revision to a previous bariatric procedure.
Studies have shown that 10 years after bariatric surgery, patients have regained an average of 20% to 30% of weight they initially lost. Bariatric revision procedures are the fastest growing segment of the bariatric surgery market.
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.
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