ReShape Medical's Integrated Dual Balloon System just burst regulatory barriers, becoming the first device of its kind to earn the FDA's stringent PMA approval for novel, high-risk devices. The Fierce 15 company's device consists of two salt water-filled silicon balloons that reduce appetite by taking up space in the stomach "or by other mechanisms that are not yet fully understood," according to the FDA.Unlike invasive weight-loss surgery, which can involve risks like malnutrition following a duodenal switch, involving removal of most of the stomach, the Dual Balloon is inserted through the mouth via an endoscope in a minimally invasive manner. The FDA says the procedure takes less than half an hour and requires mild sedation.
Wednesday, August 5, 2015
New Device Could Make Bariatric Surgery Obsolete
Varun Saxena, in a 7.29.15 Fierce Medical Devices article, reports: