Wednesday, August 5, 2015

New Device Could Make Bariatric Surgery Obsolete

Varun Saxena, in a 7.29.15 Fierce Medical Devices article, reports: 
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.

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