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July 28, 2015

FDA clears ReShape Dual Balloon system for obesity treatment in adults

ReShape Medical has received clearance from US Food and Drug Administration (FDA) to market ReShape Integrated Dual Balloon system for the treatment of obesity in adult patients with a body mass index between 30kg/m² and 40kg/m².

By admin-demo

ReShape Medical has received clearance from US Food and Drug Administration (FDA) to market ReShape Integrated Dual Balloon system for the treatment of obesity in adult patients with a body mass index between 30kg/m² and 40kg/m².

Also called ReShape Dual Balloon, the device is intended to facilitate weight loss in obese adult patients by occupying space in the stomach that may trigger feelings of fullness, or by other mechanisms that are not yet understood.

FDA Centre for Devices and Radiological Health Office of Device Evaluation acting director William Maisel said: "For those with obesity, significant weight loss and maintenance of that weight loss often requires a combination of solutions, including efforts to improve diet and exercise habits.

"This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent and can be easily removed."

"This new balloon device provides doctors and patients with a new non-surgical option that can be quickly implanted, is non-permanent and can be easily removed."

The device is delivered into the stomach through the mouth through a minimally invasive endoscopic procedure that lasts for less than 30 minutes, and is inflated with a sterile solution, which takes up room in the stomach without altering the natural anatomy.

Limited to patients with one or more obesity-related conditions such as high blood pressure, high cholesterol, and diabetes, ReShape Dual Balloon should be removed six months after it is inserted.

The FDA approval is based on a clinical trial where 187 individuals randomly selected to receive the device lost 14.3lb on average, which equates to 6.8% of their total body weight, when the device was removed at six months.

In contrast, the control group, who did not receive the device, lost an average of 7.2lb.

The trial featured 326 obese participants aged from 22-60 years, with a BMI from 30kg/m² to 40kg/m², who had at least one obesity-related health condition.

Patients treated with ReShape Dual Balloon device were able to maintain an average of 9.9lb of the 14.3lb they lost, six months after its removal.

However, the device is not recommended for use in patients who have had previous gastrointestinal or bariatric surgery or who have been diagnosed with inflammatory intestinal or bowel disease, large hiatal hernia, symptoms of delayed gastric emptying or active H Pylori infection.

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