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Medical Devices / Submissions and Approvals

FDA Approves Apollo Endosurgery Weight Loss Balloon

Aug. 7, 2015

Apollo Endosurgery, a manufacturer of minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, has received FDA approval for its Orbera intragastric balloon to assist patients with weight loss.

The balloon is aimed at helping obese patients lose and maintain weight. Thin and deflated, the balloon is placed into the stomach and filled with saline to about the size of a grapefruit to reinforce proper portion control. It is deflated and removed six months later.

The procedure is non-surgical, and is a piece of the two-part of the Orbera managed weight loss system.

Apollo reports that data on the system from a clinical trial show that the average person lost 3.1 times the weight as compared with diet and exercise alone within six months. — Michael Cipriano