Balloon system improves results in weight loss programs

For people with body mass indices (BMI) over 30, the idea of relying on diet and exercise can seem an impossible task. ReShape Medical, who developed an integrated dual balloon system, have announced the results of the device to show significant weight loss through clinical trials.

"We are excited to see the life-changing, real-world positive results from patients who have received the ReShape Dual Balloon," said Michael J. Mangano, President and CEO, ReShape Medical. "With our first patients now 12 months out from balloon insertion, outcomes reinforce the dual balloon as an effective treatment option for patients who haven't succeeded with diet and exercise alone. We are routinely achieving 10 percent total body weight loss, which scientific evidence demonstrates improves obesity-related conditions such as high cholesterol, hypertension, and others."

As the first FDA approved gastric balloon for obesity, the ReShape Integrated Dual Balloon System was designed for patients where diet and exercise had failed. Of 100 patients with a BMI, 30 to 40 were included in the first clinical trial. Participants were given two connected balloons, inserted in an outpatient procedure, for six months. Participants were given a yearlong weight loss program to follow, which included nutritional counseling and access to information on maintaining weight loss.

The average weight loss of the participants was 29.1 pounds, a 77 percent increase from the 16.4 pounds of the control group at six months. Patients also were able to reach high adherence, further doubling the amount of weight lost when compared to patients with lower adherence.

"Widely recognized by bariatric surgeons and gastroenterologists as a safe and effective weight loss tool for people with a BMI of 30 to 40, ReShape provides a much needed option for patients who have few choices left when it comes to weight loss," said Tom Lavin, MD, of the Surgical Specialists of Louisiana. "The strong weight loss outcomes in the clinical experience drove my interest in offering the procedure in my practice. We have seen great patient satisfaction and results with the ReShape Dual Balloon. It is encouraging to see the commercial results exceed the clinical results, and we look forward to continuing to help patients."