The FDA Approves a Revolutionary Non-Surgical Weight Loss Solution for People with Mild to Moderate Obesity
- Next generation dual balloon designed to create a feeling of fullness while providing patient comfort and safety
- Proven to provide more than twice the weight loss of diet and exercise alone
- Procedure integrated with 12 months of medically-supervised nutrition and exercise coaching to help enable sustained weight loss
The Future of Weight Loss is Here
For years, people with mild to moderate obesity have struggled to find a weight loss solution that works. Diet and exercise may help, but for many, the results do not last. Now, thanks to the FDA’s approval of the ReShape Integrated Dual Balloon System, a revolutionary non-surgical weight loss procedure, those struggling with their weight can finally take control of their health.
Unique Dual-Balloon Design
The ReShape Procedure is a unique dual-balloon system designed to create a feeling of fullness while providing patient comfort and safety. Its two connected balloons are larger than traditional single balloons, and they are mounted on a flexible shaft so that they can conform to the natural shape of the stomach. In addition, it is the only intragastric balloon that has measures in place to reduce the risk of migration into the intestines if it deflates.
The ReShape Procedure has already been evaluated in clinical studies and commercial use in Europe. In a study of the ReShape Procedure in commercial use in Europe, ReShape patients on average lost 47% of their excess weight and maintained 98% of their weight loss at one year. The clinical trial REDUCE showed that ReShape Patients had more than twice the weight loss of a control group receiving diet and exercise coaching alone. Additionally, these patients experienced considerable improvements in co-morbidities and had an overall high satisfaction rate with their results.
A New Option for Long-Term Health
ReShape offers a new option for those looking to achieve sustained, long-term health benefits associated with weight loss. The six months that the balloon remains in the stomach is coupled with 12 months of medically-supervised nutrition and exercise coaching to ensure that the effects last over time. With its innovative design and proven track record, ReShape is poised to revolutionize long-term weight loss solutions.
“Anyone who has struggledwith diet and exercise to lose weight knows it can be a very frustrating cycle. Still, the idea of undergoing surgery or being on medication for life is also unattractive,” said Carmelia, a ReShape patient. “The ability to make long-term changes in my lifestyle with ReShape has not only changed how I see myself in the mirror, but I how I see my future.”
“In the past, bariatric surgeons have had few options to offer patients who did not qualify for bariatric surgery,” said Ninh Nguyen, MD, Past President of the American Society for Metabolic and Bariatric Surgery. “The approval of ReShape opens up a new opportunity for these patients or patients who are not ready for surgery, by providing an effective nonsurgical treatment to help them with their weight loss and a path to a healthier lifestyle.”
About ReShape Medical®
ReShape Medical is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss. Driven by a passion to address the worldwide obesity epidemic, the company has developed a non-surgical alternative for obese patients seeking treatment. Additional company information can be found at www.pro.reshapeready.com. The ReShape device has been available in the European Union since December 2011.