Apollo Endosurgery, Inc., a company on the forefront of advancing and providing minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, announced that the US Food and Drug Administration has granted final approval of the ORBERA Intragastric Balloon, a novel component of the ORBERA Managed Weight Loss System designed to help adult obese patients lose weight and keep it off by occupying space in the patient’s stomach to simulate fullness and prevent excessive food intake.
According to previously completed clinical trials, ORBERA has been proven to significantly help the average obese individual lose 3.1 times more weight, compared to standard compliance with dieting and exercise alone for a span of 6 months.
The ORBERA balloon is entirely non-surgical, and can be greatly beneficial for obese patients deemed unfit to undergo invasive weight loss surgery, but have not responded to traditional dieting, exercising, and pharmaceutical interventions. Implanting the balloon is done via an endoscopic procedure using only a mild sedative. Once it is inside the stomach, the balloon is inflated with saline until it is about the size of a grapefruit. There is no downtime for this procedure, as it only takes 20-30 minutes. At 6 months, the endoscopic procedure is redone to deflate and remove the balloon.
While having the balloon in place will greatly aid in portion control, patients are strongly recommended to work closely with a dietician, psychologist, and exercise physiologist to facilitate their adjustment to the weight loss program, keep them motivated, and help them achieve and maintain long term weight loss goals. This holistic program takes about 12 months, extending well after the balloon is removed after the first 6 months.
“While new to the United States, ORBERA™ is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results,” said Todd Newton, Chief Executive Officer of Apollo Endosurgery. “ORBERA™ is a proven, innovative and non-surgical solution to help fight the obesity epidemic and treat patients before their disease progresses and requires more invasive treatments. With the FDA approval of ORBERA™, Apollo can now offer this safe and effective solution to patients and their physicians in the United States.”
“For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery. The approval of ORBERA™ fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients with less invasive options that can assist them in reaching their long-term weight loss goals,” said Christine Ren-Fielding, M.D., a New York-based bariatric surgeon. “ORBERA™ gives us a new weight loss option to help address what has become a critical health issue in the United States.”
To learn more about ORBERA, visit Orbera.com.