ReShape Medical™, Inc. announced today that it has initiated a U.S. Investigational Device Exemption (IDE) clinical study to assess the safety and effectiveness of its non-surgical, dual-balloon device for weight loss. The ReShape Balloons are designed to be a treatment for the millions who want support with weight loss, without the invasiveness of surgery. The ReShape device occupies existing space in the stomach to reduce its capacity for food. The balloons remain in place for six-months and are then removed.
The first U.S. study participant received the ReShape Balloons Treatment at The N.E.W. Program in Newport Beach, Calif., under the care of Brian Quebbemann, M.D., FACS, and Surgical Director of The N.E.W. Program. "At 6'2" and 263 pounds, this 31-year old man did not qualify for bariatric surgery, and had exhausted his efforts with diets that didn't work," said Dr. Quebbemann.
Dr. Quebbemann added, "Countless Americans have grown beyond a healthy weight and struggle with conventional methods of weight loss, but can't or won't undergo surgery. This group is ideally suited for a non-surgical weight loss treatment such as the ReShape device being evaluated in this study."
"We are very pleased to initiate the U.S. IDE clinical study to evaluate the safety and efficacy of this emerging weight loss treatment. There are millions of Americans who have a BMI over 30, but there are few options available to help them with their weight loss," said Bill Murray, President and CEO of ReShape Medical, Inc. "We are pioneering the next-generation weight loss solution."
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