FDA Approves ORBERA Balloon For Weight Loss

The ORBERA Intragastric Balloon from Apollo Endosurgery, Inc. was approved by the FDA on August 6, 2015 as a non-surgical weight reduction treatment for adults with weight problems. The ORBERA balloon is designed to take up space in the stomach and help with weight reduction by reinforcing part control. The balloon remains set up for half a year and is part of the 12-month supervised diet and exercise program, known as the ORBERA Managed Weight Loss System.

The authorization comes only a week following the FDA approved another gastric balloon weight device, the ReShape Integrated Dual Balloon System from ReShape Medical. The ORBERA Intragastric Balloon System is a medical weight reduction device that has a soft and durable silicone gastric balloon that temporarily gets placed into the stomach to consider up space.

Balloon placement is done during a non-surgical endoscopic procedure with an outpatient basis under slight sedation. The procedure requires about 20 to 30 minutes and the individual can usually go home the same day. The balloon is set up unfilled and then filled with salt water (saline) until it expands to about how big is a grapefruit.

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The balloon can be filled up with varying amounts of saline (from 400 to 700 cc) to best match a patient’s anatomy. The balloon is left in the tummy for half a year and then removed. The removal process is another minimally invasive endoscopic procedure which involves emptying the balloon and then taking it out of the stomach. Month period with the balloon set up and for an additional six weeks During the six, the ORBERA Managed Weight Loss System requires patients to interact with a support team of experts to build up a personalized weight loss plan.

The program was created to help patients overcome the issues of retraining appetite, adopt healthy nutritional habits, set up a reasonable workout routine, and stay motivated and be successful with weight reduction goals. 8,000. The ongoing company will not expect insurance to cover the cost, at least not primarily. The ORBERA balloon was already used worldwide in more than 200,000 patients in about 80 countries with a history of safety. The scientific trial study included 255 participants who had been adopted for one-year. During that right time, 125 patients received the ORBERA balloon and got it in place for half a year.

After these devices was removed, these were followed for yet another six months. 130 patients participated in a 12-month behavior changes program but did not receive the device. The results showed that the group of people who used the ORBERA balloon lost more weight than those who did not. After six months, patients with ORBERA lost typically 21.8 pounds (10.2% of body weight) in comparison to an average of 7.0 pounds (3.3% of bodyweight) in patients who didn’t receive the device. Three months after the device was removed (9 a few months into the study), some of the patients in the ORBERA group gained some weight, but maintained typically 19.4 pounds of weight loss.