ReShape Medical announced results from the use of the ReShape integrated dual balloon system since FDA approval, which demonstrate a significant increase in weight loss over the clinical trial experience.
Data obtained from the ReShape Patient Portal, an online support community where patients can interact with each other and track their progress, show benefits of the ReShape Dual Balloon as well as its associated coaching.
The first 100 patients who received the ReShape Procedure in the commercial setting lost an average of 29.1 pounds, a 77% increase compared to patients in the clinical trial who lost an average of 16.4 pounds after six months.
ReShape was also able to ascertain that patients who remained highly engaged on the Portal lost two times as much weight over a six-month period than patients with low engagement.
"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 Chief Executive Officer, 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% total body weight loss, which scientific evidence demonstrates improves obesity-related conditions such as high cholesterol, hypertension, and others."
Two studies were also presented to leaders in bariatric surgery at the annual ObesityWeek national medical conference this week. Both studies showed impressive weight loss results with at least 33.2%, and up to 37.6%, excess weight loss (EWL) achieved for patients with three or more months of treatment, as compared to the clinical study results of 27.9% EWL.
"Widely recognized by bariatric surgeons and gastroenterologists as a safe and effective weight loss tool for people with a BMI of 30-40, ReShape provides a much needed option for patients who have few choices left when it comes to weight loss," said Dr. Tom Lavin, Surgical Specialists of Louisiana.
"The strong weight loss outcomes in the clinical experience drove my interest in offering the ReShape 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 with the ReShape Procedure."
These strong outcomes are changing the lives of patients. ReShape patient Charlie Walker who has lost 81 pounds in 12 months, credits ReShape for his renewed health and quality of life. He's working out every day and feeling great—enjoying all the things he was missing out on because of his weight. As Charlie says, "ReShape was the best decision I've ever made."
Andrea Walker struggled with losing weight that she gained after raising her four children. After diet and exercise failed, Andrea lost 50 pounds in just five months with ReShape. Andrea says, "I have more energy than I've had in years!"
Introduced in the U.S. last year, the ReShape Integrated Dual Balloon System was the first FDA-approved dual gastric balloon for obesity, establishing a brand new category of treatment for people who have been struggling to lose weight but have not been successful with diet and exercise alone and are not ready for or do not want surgery.
Specifically for people with a Body Mass Index (BMI) of 30-40 and one co-morbidity, the ReShape Procedure is part of a comprehensive, yearlong weight loss program aimed at teaching patients healthy habits for sustained weight loss and long term lifestyle change. During a short, outpatient procedure, two connected balloons are placed into the stomach and filled with saline where they remain for six months.
During balloon treatment, and for six more months following removal, the patient receives nutritional counseling and access to exclusive tools to help them achieve their weight loss goals.