FDA approves ReShape Integrated Dual Balloon System to treat obesity- ReShape Medical

The FDA has approved a new balloon device to treat obesity without the need for invasive surgery. The ReShape Integrated Dual Balloon System (ReShape Dual Balloon) from ReShape Medical, is intended to facilitate weight loss in obese adult patients. The device likely works by occupying space in the stomach, which may trigger feelings of fullness, or by other mechanisms that are not yet understood.

The ReShape Dual Balloon device is delivered into the stomach via the mouth through a minimally invasive endoscopic procedure. The outpatient procedure usually takes less than 30 minutes while a patient is under mild sedation. Once in place, the balloon device is inflated with a sterile solution, which takes up room in the stomach. The device does not change or alter the stomach�s natural anatomy. Patients are advised to follow a medically supervised diet and exercise plan to augment their weight loss efforts while using the ReShape Dual Balloon and to maintain their weight loss following its removal. It is meant to be temporary and should be removed six months after it is inserted.

Comment; Trial evidence showed patients had lost 42% of excess weight in a 6-month period; the commonly cited expectation for Lap-Band, the least effective type of surgery, is about 50%. But the ReShape device does not require surgery; it can be inserted and removed in a physician's office.

Comment: Six months following the device removal, patients treated with the ReShape Dual Balloon device kept off an average of 9.9 pounds of the 14.3 pounds they lost.

Comment: There are currently three other FDA-approved devices to treat morbid obesity: the Allergan LAP-Band (now owned by Apollo Biosurgery, FDA approved in 2001.The Maestro Rechargable System from Entero-Medics, FDA approved in January 2015 and the Ethicon Endo-Surgery Realize Adjustable Gastric Band FDA approved 28 September 2007.All have CE Marks.