The ORBERA Intragastric Balloon from Apollo Endosurgery, Inc. was approved by the FDA on August 6, 2015 as a non-surgical weight loss treatment for adults with obesity.
The ORBERA balloon is designed to occupy space in the stomach and assist with weight loss by reinforcing portion control. The balloon remains in place for six months and is part of a 12-month supervised diet and exercise program, known as the ORBERA Managed Weight Loss System.
The approval comes only a week after 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 loss device that features a soft and durable silicone gastric balloon that temporarily gets placed into the stomach to take up space.
Balloon placement is done during a non-surgical endoscopic procedure on an outpatient basis under mild sedation. The procedure takes about 20 to 30 minutes and the patient can usually go home the same day.
The balloon is put in place empty and then filled with salt water (saline) until it expands to about the size of a grapefruit. The balloon can be filled with varying amounts of saline (from 400 to 700 cc) to best match a patient’s anatomy.
The balloon is left in the stomach for six months and then removed. The removal procedure is another minimally invasive endoscopic procedure that involves emptying the balloon and then taking it out of the stomach.
During the six month period with the balloon in place and for an additional six months, the ORBERA Managed Weight Loss System requires patients to work together with a support team of experts to develop a personalized weight loss plan.
The program is designed to help patients overcome the challenges of retraining appetite, adopt healthy nutritional habits, establish a reasonable exercise routine, and stay motivated and succeed with weight loss goals.
According to Dennis McWilliams, founder of Apollo Endosurgery, the ORBERA procedure, including the 12-month diet and exercise program, will cost about $6,000 to $8,000. The company does not expect insurance to cover the cost, at least not initially.
The ORBERA balloon has already been used worldwide in more than 200,000 patients in about 80 countries with a track record of safety.
Clinical Trial Results
The clinical trial study involved 255 participants who were followed for one-year. During that time, 125 patients received the ORBERA balloon and had it in place for six months. After the device was removed, they were followed for an additional six months. 130 patients participated in a 12-month behavior modification 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 an average of 21.8 pounds (10.2% of body weight) compared to an average of 7.0 pounds (3.3% of body weight) in patients who did not receive the device.
Three months after the device was removed (9 months into the study), some of the patients in the ORBERA group gained some weight, but maintained an average of 19.4 pounds of weight loss.
The ORBERA weight loss procedure is approved for use in adult patients with obesity (BMI 30 to 40) who have not been able to lose weight through diet and exercise. It is to be used while a patient participates in a supervised diet and behavior modification program.
This new option can help motivated patients lose weight by reinforcing portion control and learning healthy habits from a team of experts to achieve long term weight loss success.
The ORBERA Intragastric Balloon System is a now a product of Apollo Endosurgery, Inc. of Austin, TX, USA. Apollo Endosurgery, a leading developer of medical devices for endoscopic surgical procedures, acquired the LAP-BAND and ORBERA technologies when they purchased the obesity intervention division of Allergan, Inc in 2013.
More information about the ORBERA Weight Loss System can be found at orbera.com.
Source: Apollo Endosurgery, Inc. Press Release “Apollo Endosurgery, Inc. Announces FDA Approval of the ORBERA™ Intragastric Balloon, a Non-Surgical Solution to Assist Patients in Weight Loss” August 6, 2015.