Apollo Endosurgery, Inc. Announces FDA Approval of the ORBERA™ Intragastric Balloon, a Non-Surgical Solution to Assist Patients in Weight Loss, and we are please to announce that we are now seeing patients for consultations!
Dr. Trace Curry
• 3.1 times the weight loss than diet and exercise alone
• Safe and effective weight loss solution with over 220,000 placements worldwide
Austin, TX (August 6, 2015) — Apollo Endosurgery, Inc., a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, today announced that the U.S. Food and Drug Administration (FDA) has approved the ORBERA™ Intragastric Balloon to assist adult patients suffering from obesity – with a body mass index (BMI) of 30 to 40 – in losing and maintaining weight.
ORBERA™ is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.
In the U.S. pivotal ORBERA™ clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, patients suffering from obesity with a BMI between 30 and 40 were randomized to treatment or control in a 1:1 ratio. The treatment group underwent placement of the ORBERA™ balloon followed by removal after six months. They concurrently participated in a 12-month behavioral modification program. The control group participated in the 12-month behavioral modification program alone. For patients in the treatment group, the device was removed at month six, with regular office visits continuing through one year.
• At month six, the ORBERA™ group achieved a mean of 38.4 percent Excess Weight Loss (EWL).