Allergan Medical has announced that the ORBERA System for weight loss is now available in Canada and Australia. The ORBERA System is a non-surgical and non-pharmaceutical medical device that can help obese and overweight patients lose weight without the risk of surgery or drugs.
The ORBERA System, also known as the BIB Intragastric Balloon System, features a silicone balloon that is inserted via endoscopic methods into the stomach and filled with saline to assist with weight loss. By partially filling the stomach, the balloon helps a patient eat less and feel full, faster. The balloon is only temporary, remaining in the stomach no longer than six months.
As part of a managed weight loss program, the ORBERA System provides a jump start to weight loss. It is intended to help educate and teach patients about portion control and healthy eating. The ORBERA system is used in conjunction with one year of diet and behavior counseling to increase the likelihood of long-term, sustained weight loss.
The BioEnterics Intragastric Balloon (BIB) system was initially released in the mid-1990′s. It has been used extensively throughout Europe, where it has become a clinically accepted treatment for weight loss with proven results. In addition to the recent approval in Australia and Canada, it is also available in Mexico and South America.
The ORBERA System has been shown to be effective in initiating behavioral change and promoting weight loss by controlling food intake and reducing hunger. As a weight loss solution, it is less invasive and aggressive than bariatric surgery with minimal risk of major complications. It is also completely reversible and easy-to-use.
While the medical device is not FDA approved for use in the United States, clinical trials are currently in progress. The FDA study, titled “Safety and Effectiveness of the BioEnterics Intragastric Balloon (BIB) System to Assist in the Weight Management of Obese Subjects,” has an estimated completion date of September 2010. The purpose of the FDA study is to determine the safety and effectiveness of the BIB system. If the study is successful, it could still be a couple of years before the ORBERA System is available in the United States.
The FDA study is sponsored by Allergan Medical, the same company that is behind the LAP-BAND System. The LAP-BAND System is a surgically implanted medical device that helps a person lose weight. It is one of the leading types of bariatric surgery in the United States, continuing to gain in popularity since it was approved by the FDA in 2001 as a treatment for obesity.
Source: Clinical Trial #NCT00730327