Medical Device and Diagnostic Industry Features ReShape® Procedure

FDA Approves First-of-Its-Kind Non Surgical Weight-Loss Device

FDA approves the ReShape Dual Balloon, a temporary device that is introduced endoscopically in patients who are morbidly obese.

There’s a new device to fight morbid obesity and it involves a nonsurgical procedure to boot.

FDA announced Tuesday that it has approved the ReShape Dual Balloon Device from ReShape Medical® to treat severely obese patients who have related conditions such as diabetes, high blood pressure and high cholesterol. The temporary balloons are introduced in the body through the mouth and then inflated.

It is intended to help patients with a BMI of 30 to 40 see successful and sustained weight loss. It works by filling up space inside the person’s stomach forcing obese patients to eat small meals. The temporary device is inside a patient for a period of six months during which the company works with each patient to make them understand the principles of portion control, diet and exercise.

“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,” said William Maisel, acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. “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.”

Medical Device and Diagnostic Industry Features ReShape^® Procedure

FDA Approves First-of-Its-Kind Non Surgical Weight-Loss Device

FDA approves the ReShape Dual Balloon, a temporary device that is introduced endoscopically in patients who are morbidly obese.

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