2015-08-06 13:43:46 UTC
Aug. 6, 2015
AGA is committed to supporting new gastric technologies and will guide GIs in obesity management.
FDA has approved ORBERA™ Intragastric Balloon, from Apollo Endosurgery, Inc., the second obesity device the agency has approved this week.
The AGA Center for GI Innovation and Technology has been working with device companies — such as Apollo — and FDA for the past several years to foster conversations and pave the path towards approval and adoption of these new technologies.
“Gastroenterologists are at the center of obesity management and are poised to play a critical role in patient management and support through the weight loss process,” said Michael Camilleri, MD, AGAF, president of the AGA Institute. “We are pleased to see these new innovations obtain FDA approval, and we will be working to support gastroenterologists and hepatologists as they take on this important role in the multidisciplinary management of obesity.”
“I believe the inflection point in endolumenal bariatrics occurred several years ago at the first AGA Tech Summit, where AGA fostered a dialog between FDA, industry, physicians and investors. We are excited to see the fruits of that labor and greatly appreciate the efforts of the FDA and the AGA Center for GI Innovation and Technology for helping to bring new obesity devices to market,” said Dennis McWilliams, president and founder, Apollo Endosurgery.
ORBERA™ has been approved to assist adult patients suffering from obesity — with a body mass index of 30 to 40 — in losing and maintaining weight. Data on ORBERA™ collected in the U.S. clinical trial has shown that the average person lost 3.1 times the weight as compared with diet and exercise alone within six months.
The ORBERA™ balloon is part of the ORBERATM Managed Weight Loss System, a comprehensive, non-surgical two-part program that includes a balloon filling space in a patient’s stomach to reinforce proper portion control. Learn more about ORBERA™.