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FDA approves ReShape System

FDA approves ReShape Integrated Dual Balloon System

Next generation dual balloon designed to create a feeling of fullness while providing patient comfort and safety
Procedure integrated with 12 months of medically-supervised nutrition and exercise coaching to help enable sustained weight loss

ReShape Medical has received FDA approval for its ReShape Integrated Dual Balloon System, a first-of-its-kind non-surgical weight loss procedure for people with mild to moderate obesity. The ReShape Procedure provides a new option for adults with a BMI30-40 with a related comorbidity who have been unsuccessful at diet and exercise alone, and do not want or do not qualify for bariatric surgery.

“Many Americans who face the risk and consequences of obesity have struggled with a lack of effective weight loss options when their BMI is in the 30-40 range,” said Dr John Morton, President of the American Society for Metabolic and Bariatric Surgery. “Options like ReShape address a significant gap that exists between diet and exercise, weight loss medications and surgery, offering a minimally invasive, reversible option which we hope will promote long-term healthy habits.”

ReShape is a next generation technology with features that are designed to enhance performance in three important areas. First, two connected balloons have a larger fill volume than a typical single balloon.  Second, it is designed for greater comfort by mounting the two balloons on a flexible shaft that allows the device to conform to the natural shape of the stomach.  Finally, the ReShape Integrated Dual Balloon is the only intragastric balloon that is designed to mitigate the potential for migration of a deflated balloon from the stomach into the intestines.

The dual balloon is inserted in the stomach endoscopically and filled with saline. It does not change or alter the natural anatomy in any way and remains in the stomach for six months. During this time and for the six months after the balloon is removed, ReShape patients receive comprehensive counselling and support services that include frequent in-office coaching sessions. 

“While intragastric balloons have been used successfully outside of the US for many years, there has been little design improvement or innovation of this treatment,” said Rick Thompson, President and CEO of ReShape Medical. “We looked closely at previous balloons when designing our dual balloon and we feel confident that our unique, next-generation design will help to deliver sustained results and significant life changes for patients.”

The ReShape Integrated Dual Balloon System was evaluated in the REDUCE pivotal trial, the results of which showed that patients who had the ReShape procedure lost 2.3 times as much weight as a control group that received diet and exercise coaching only. There were also measurable and sustained improvements in co-morbidities and strong patient satisfaction. 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.

Jamie Ponce

“Through clinical studies in the US and abroad, ReShape has now been used by hundreds of patients,” said Dr Jaime Ponce, lead investigator on the REDUCE trial. “Positive data from the rigorously designed pivotal study, coupled with commercial experience in Europe, demonstrate that ReShape can provide an important new non-surgical option to help patients in the US lose weight and give them the tools needed to keep it off.” 

The company plans to make the ReShape procedure available to patients first in select markets, as physicians and allied health professionals are trained on the procedure and support program to optimize patient outcomes. The ReShape procedure, including the 12 months of premium coaching and support, will be available on a self-pay basis and price will vary by healthcare provider and market.

“In the past, bariatric surgeons have had few options to offer patients who did not qualify for bariatric surgery,” said Dr Ninh Nguyen, 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.”

The ReShape device has been available in the European Union since December 2011.

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