This week ReShape Medical announced that its REDUCE Trial for the ReShape Duo Intragastric Balloon has met its primary efficacy endpoints. It is the first medical device company to do so in a US randomized, pivotal trial for weight loss.
The ReShape Duo is a non-surgical treatment for weight loss. It is silicone dual-balloon system which is designed to occupy space in the stomach. The balloons reduce the capacity for food, allowing patients to feel full and satisfied with smaller portions. Serving as built-in portion control, the balloons remain in the stomach for six months. During this time the patient learns to live a healthier lifestyle with the support of dietitians, doctors, and nurses. To place the device in the stomach, the patient undergoes a 20 minute outpatient procedure. Using a flexible tube called an endoscope, un-inflated balloons are carefully placed down the throat and into the stomach. Once they are in the stomach they are inflated with saline. The balloons do not alter the stomach’s natural anatomy, but rather occupy space to reduce the capacity for food. The ReShape Duo is then removed in a similar 20 minute out-patient procedure.
The REDUCE Trial involved 326 patients in eight U.S. sites and its endpoints assessed weight loss and responder rates. An endpoint means a pre-determined measure that helps determine the efficacy or potential success of what’s being measured in a trial. The balloon makers said in a press release that they plan to submit a Premarket Approval application to the FDA in the second quarter of 2014.
Dr. Jaime Ponce, expert bariatric surgeon and Principal Investigator of the study said, “Meeting the primary endpoints is an important accomplishment, as it convincingly demonstrates the superiority of the ReShape procedure over diet and exercise alone. The ReShape procedure offers a new alternative to help patients kick-start weight loss and learn new behaviors. We are excited about what this new treatment option may do for millions of people needing to lose excess weight.” The procedure would fill a big gap in the weight loss treatment continuum between diet, exercise, and medications and more invasive options such as weight loss surgery. ReShape Medical’s website says that most patients lose, on average, 1/3 of their excess weight in 6 months. In comparison, patients who undergo gastric bypass surgery for weight loss ultimately lose on average, 50 to 70 percent of their excess weight.
While the balloons are currently investigational in the United States and only available through clinical trial, they are available in other countries, including some European countries and Canada. According to a 2012 article, many Americans are already receiving the treatment north of the border. At the time, Americans accounted for nearly a third of patients receiving balloons in Canadian clinics just across the border. You access the article here.
Weight Loss Studies & Clinical