ReShape Duo Delivers Weight Loss In Sham-Controlled Pivotal Trial
This article was originally published in The Gray Sheet
Executive Summary
The REDUCE US pivotal trial of ReShape Medical’s Duo dual intragastric balloon weight-loss therapy is the first prospective randomized pivotal trial of a device to treat obesity to meet its primary efficacy endpoints, according to the San Clemente, California, company.
You may also be interested in...
EnteroMedics Inflates Neuromod-Obesity Offering With ReShape Balloon
The deal, worth $61m in cash and stock, will add ReShape's Dual Weight Loss Balloon to EnteroMedics' vBloc neurometabolic therapy and Gastric Vest System for the treatment of obesity.
ReShape Dual Balloon Enters U.S. Market, Headlining Week Of Obesity Device News
It was a banner day for minimally invasive weight-loss devices July 28. FDA approved ReShape Medical's intragastric balloon and Aspire Bariatrics submitted an application for its AspireAssist aspiration therapy system for obesity. Two days later, GI Dynamics announced the termination of a pivotal study for its Endobarrier device.
ReShape Dual Balloon Enters U.S. Market, Headlining Week Of Obesity Device News
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.