Stomach-Draining Device Makes Play For Obesity Surgery Patients
This article was originally published in The Gray Sheet
Approved as a long-term treatment option for obese patients with a body-mass index of 35 to 55, Aspire Bariatrics is positioning its AspireAssist device as a less-invasive alternative to bariatric surgery in the population of morbidly obese individuals who are most often recommended for a procedure. The system includes an endoscopically implanted tube and a port used by the patient to drain contents of the stomach and reduce calories absorbed.
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It was a banner day for minimally invasive weight-loss devices July 28. FDA approved ReShape Medical's intragastric balloon and, on the same day, Aspire Bariatrics reached a key milestone with the PMA submission for its AspireAssist aspiration therapy system for obesity. Two days later, GI Dynamics announced the termination of a pivotal study for its Endobarrier device.
Higher-risk devices, based on feasibility trial adverse event rates, would be matched to steeper effectiveness targets in pivotal studies for weight-loss under a plan outlined by the agency.
Attorneys say Sarepta did not have an obligation to report its appeal, particularly since winning a formal dispute filing with the US FDA is a long shot.