Two New Balloon Devices Approved for Obesity Treatment

Topic: Obesity/Weight management date: 08/07/2015 Featured Expert: N/A

The FDA has approved two new obesity devices, balloon systems that are temporarily implanted in the stomach and cause patients to feel full.

Two new minimally invasive obesity devices have been granted FDA approval in the battle to achieve weight loss: ReShape™ and ORBERA™ balloon systems are temporarily implanted in the stomach and then filled with saline via endoscopic procedures that take less than 30 minutes and require only mild sedation. Both devices are designed to be left in place for 6 months and work by causing the patient to feel a sense of fullness without altering the natural anatomy of the stomach. ReShape consists of dual balloons that are filled and sealed separately and is indicated for obese adults having a BMI of 30 to 40 kg/m2 with one or more obesity-related conditions. ORBERA consists of a single balloon and is indicated for obese adults with a BMI of 30 to 40 kg/m2 who have been unable to lose weight through diet and exercise alone. Patients receiving either device should continue to participate in a diet and exercise program.

The balloon systems are the second and third devices to be approved in 2015 (Maestro [EnteroMedics], an electrical stimulator that works by blocking nerve activity between the brain and stomach, was approved in January), after a period of several years with no approvals.

For more on the latest developments in obesity management, the Lifestyle and Obesity Management session being held at #CMHC2015 on Friday, October 23, will include a comprehensive look at the “Long-Term and Metabolic Effects of Bariatric Surgery,” presented by faculty experts Lee M. Kaplan, MD, PhD, who was director of the recent FDA workshop on device development for obesity and metabolic diseases, and Francesco Rubino, MD, whose work helped transform bariatric surgery from a mere weight loss therapy to one intentionally aimed at treating diabetes and other metabolic illnesses.