ORBERA Managed Weight Loss System receives final approval from FDA

Aug 14 2015

The ORBERA™ Managed Weight Loss System received its final approval on Wednesday, August 5th and Ultimate Bariatrics is proud to be one of the first in the country to offer this new tool in helping people achieve their weight loss goals. Ultimate Bariatrics is excited to share that the U.S. Food and Drug Administration has approved ORBERA™, a safe and effective weight loss solution with 20 years of global experience and real world results. The ORBERA™ System, which combines a gastric balloon with nutritional coaching and exercise programs, is indicated for adult patients suffering from obesity with a BMI of 30 to 40 who desire a weight loss solution that does not require more invasive traditional surgery.

While new to the United States, the ORBERA™ device has more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results. During clinical study, participants who used the ORBERA™ balloon for its intended six-month period were able to lose, on average, three times as much bodyweight as participants who only adhered to a diet and exercise plan. ORBERA™ is easier to administer to patients, simply by being placed into the stomach through the mouth using a minimally invasive endoscopic procedure with mild sedation, and then inflated with saline solution to the size most suited to the patient's body structure.

Adam Smith D.O., FACOS has been chosen by Apollo Endosurgery, the makers of ORBERA™ to be a spokesperson for the ORBERA™ balloon, and participated in its clinical trials before FDA approval. In his ongoing quest to stand up for the rights of the obese population, Dr. Smith was appointed as a spokesperson by the Obesity Action Coalition and Allergan as a part of the Voice My C.H.O.I.C.E. campaign, he served as the President of the American College of Osteopathic Surgeons in 2013, and is a member of many professional medical societies.

SOURCE Apollo Endosurgery