November 8, 2013 | By Anabela Farrica
Yesterday, November 7th, ReShape Medical announced it met the primary efficacy endpoints in its REDUCE trial for the ReShape Duo Intragastric Balloon, a non-surgical approach for weight loss.
With this achievement, ReShape Medical becomes the first company in the U.S. to meet its primary efficacy endpoints in a randomized, sham-controlled, pivotal trial for obesity. The assessed endpoints included weight loss and responder rates. The trial had met with great interest from patients and investigators, having reached full enrollment in less than six months. It involved 326 patients distributed over eight trial sites all over the U.S.
The main difference between the Reshape Duo Intragastric Balloon and other devices for obesity treatment is that its placement does not require any incisions or sutures. The balloon is positioned into the stomach endoscopically and then filled with saline solution. As a consequence, the device takes up a considerable portion of the stomach’s volume, causing the patients to feel full sooner and thus eating less. The device does not induce any changes in the patient’s anatomy and it is reversible. Treatment is meant to be carried for a 24 week period, during which patients work with several doctors and dieticians to learn healthy diet and exercise habits to help them during and after the treatment period.
Obesity is extremely prevalent worldwide, affecting 35.7% of adults in the U.S. alone, and it is a major risk factor for several ailments. According to Jaime Ponce, Principal Investigator in the REDUCE trial, “The ReShape procedure offers a new alternative to help patients kick-start weight loss and learn new behaviors”. ReShape Medical expects to submit Premarket Approval application to the FDA in the second quarter of 2014 and this initial success represents an important step towards regulatory approval.