The U.S. trial evaluating the device in 325 patients is almost completed, and the company recently announced that the primary endpoints that assessed weight loss and responder rates had been met. The company plans to file for FDA approval in the second quarter of 2014.
Courtesy ReShape Medical
The ReShape Duo intragastric device is made up of two balloons that contain a total of about 900 mL of fluid, which occupy space in the stomach without the discomfort and distension that can occur with one large balloon.
Dr. Rothstein said that other nonsurgical devices being developed include those that do not require endoscopic placement, such as bezoars or balloons that are swallowed by the patient and function as temporary "space-occupying devices," he said. One example is a capsule that contains beads, which swell up in the stomach and take up space after the capsule is swallowed – which may affect satiety and result in weight loss if ingested before a meal, he said.
Techniques that bring aspects of the proximal stomach together represent another approach, using devices to sew and stitch up the stomach, compartmentalizing the stomach, creating "if you will, an endoscopic gastric sleeve," he said, noting there are not much data available on this approach.
Data from studies that are sham-controlled and have adequate sample sizes are needed to determine the role of these therapies, as they are developed, and they need to be shown to have "reasonable durability," and a safety profile with minimal complications, with cost-effectiveness data, Dr. Rothstein said. And as they become available, it will be necessary to "tease out" which patient groups respond best to which therapy, such as balloons or bezoars, or gastric bypass surgery, he added.