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Product submission

ReShape submits dual balloon system application to FDA

ReShape Medical has previously anticipated a launch in the US in mid-to-late 2015

ReShape Medical has submitted a Premarket Approval (PMA) application to the FDA for the ReShape Integrated Dual Balloon System, the first and only dual balloon for non-surgical weight loss designed for people with a BMI30-40.

The company claims that the ReShape system is the first device to meet its primary effectiveness endpoints in a US, randomised, sham-controlled pivotal trial for weight loss. ReShape’s PMA submission includes data from the company's REDUCE Trial involving 326 patients at eight sites in the US that measured the safety and effectiveness of the procedure as an adjunct to diet and exercise. As previously reported, patients undergoing the ReShape procedure lost significantly more weight than the sham-control subjects who received diet and exercise alone. The device had an excellent safety profile.

Richard Thompson

“With this PMA submission, ReShape Medical is on track with our regulatory timeline, achieving an important milestone in our mission to offer an effective, non-surgical treatment option to those for whom other weight loss efforts have not proven sufficient,” said Richard Thompson, President and CEO of ReShape Medical.

While an estimated 50 million Americans are classified as obese with a BMI of 30-40, many neither qualify for nor want surgery, creating a significant unmet need for additional treatment options. Obesity is a major risk factor for serious health complications, many of which are the leading causes of preventable death, including heart disease, stroke, type 2 diabetes and certain types of cancer, among others.

Jaime Ponce

“Meeting the primary endpoints is an important accomplishment, as it convincingly demonstrates the superiority of the ReShape procedure over diet and exercise alone,” said Dr Jaime Ponce, Dalton, Georgia, Principal Investigator in the REDUCE trial. “The ReShape procedure offers a new alternative to help patients kick-start weight loss and learn new behaviours. We are excited about what this new treatment option may do for millions of people needing to lose excess weight.”

The ReShape procedure is designed to help patients lose weight and facilitate behavior change. The integrated dual balloon is inserted endoscopically during an outpatient procedure and remains in the stomach for six months. The balloon takes up space in the stomach and helps patients feel full. While the stomach-filling balloons are in place, patients are counselled by health care professionals on nutrition, exercise and behaviour modification to help them develop a healthier lifestyle. This programme continues for an additional six months after removal of the balloons to encourage new habits and lasting results.

ReShape Medical has previously anticipated a launch in the US in mid-to-late 2015. The ReShape device has been available in the European Union since December 2011.

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