Non-invasive weight loss treatment from Obalon Therapeutics, Inc. receives FDA approval
Orange County, CA - September 27th 2016 - Since 1980, the amount of obese individuals in the world has doubled. This rise accounted for 1.9 billion people 18 and over being overweight in 2014, with 600 million of those individuals being obese. In America, upwards of a third of the adult population is living with obesity. Although looking at the scale can be cause for distress, obesity is preventable.
Obalon Therapeutics is ready to help those who have tried diet and exercise with pabulum results with the Obalon balloon system. The objective of the program is to jump start weight loss and aiding patients to convert to a healthier lifestyle. Eligibility for candidacy requires patients to be at least 22 years of age and have a body mass index (BMI) of 30 to 40 kg/m2. The program is a 12 month process including a healthy diet and exercise routine.
The Obalon is a swallowable, less invasive means of weight loss than a surgery like Gastric bypass. The Obalon system is a “balloon” made up of a small capsule attached to a tube, which the patient swallows. Gas is then used to inflate the balloon before the tube detaches and is removed. This typically takes less than ten minutes.
The purpose of the balloon is to stay in the stomach and take up space to feel full more quickly. For the first six months of the program, multiple balloons, up to three, will be deposited into the stomach. Removal of the balloon solely requires an endoscopy, making this option non-surgical and fully reversible. For retainable results, the patient is required to follow a disciplined diet and exercise routine 6 months prior to the procedure and after.
Dr. Shelby Sullivan, Director of the Gastroenterology Bariatric and Metabolic Program at the University Of Colorado School Of Medicine has said that, “patients tolerated the administrations of the Obalon balloon remarkably well with no recovery time needed. This is in contrast to other currently approved intragastric balloon devices, where most patients cannot immediately return to normal activities.”
In a double-blind clinical trial of 387 patients, about 65% of patients who had the Obalon balloon system inserted experienced weight loss of at least 5% of their total body weight; twice as many as the control group. The Obalon announced its FDA approval on September 12th, 2016 and is expected to be available to physicians in early 2017 in the completion of the provided training program.
