ReShape Medical, a development-stage manufacturer of medical devices, has initiated a US 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 those who need support with weight loss, without the invasiveness of surgery. The ReShape device is an endoscopic device which occupies existing space in the stomach to reduce its capacity for food. The balloons remain in place for six-months and are then removed.
ReShape Medical said that the first US study participant has received the ReShape Balloons Treatment at The NEW Program in Newport Beach, California, under the care of Brian Quebbemann, surgical director of The NEW Program.
Bill Murray, president and CEO of ReShape Medical, said: “We are pleased to initiate the US IDE clinical study to evaluate the safety and efficacy of this emerging weight loss treatment. There are millions of Americans who have a Body Mass Index (BMI) over 30, but there are few options available to help them with their weight loss. We are pioneering the next-generation weight loss solution.”
Dr Quebbemann said: “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. 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.”