Release Date: 06/18/2008
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Lahey Clinic is one of four centers to implant device that aids weight loss and controls diabetes
BURLINGTON, MA—Physicians at Lahey Clinic are investigating the safety and efficacy of a new medical device, the EndoBarrier Gastrointestinal Liner, that may mimic the effects of gastric bypass surgery—including weight loss and control of type 2 diabetes—before any surgery takes place. There are only three other centers in the U.S. participating in this trial.
Obesity and diabetes are rapidly growing worldwide health care epidemics. Each affects more than one billion people. Together, diabetes and obesity are leading to significant increases in health care costs and death rates, as well as a substantial reduction in quality of life for those affected.
The EndoBarrier is initially being tested as a short-term, removable weight loss device that is implanted (through the mouth) for up to three months in patients who are candidates for bariatric surgery to help them lose weight prior to surgery. Eventually, the device will be tested for longer periods of time. It consists of an impermeable sheath that lines the first two feet of small intestine as it leaves the stomach and prevents food from making contact with the intestinal wall or from mixing with the digestive juices. The device allows food to bypass the first part of the small intestine, resulting in weight loss over a three-month period. The device also alters the metabolic pathway in the same way that gastric bypass does and is believed to produce a similar effect on the resolution of type 2 diabetes.
Principal Investigator Dmitry Nepomnayshy, MD, reported results from three of his patients at the Society of American Gastrointestinal and Endoscopic Surgeons annual meeting in April. Patients who received the device lost between 11 and 26 pounds in three months. All went on to have gastric bypass surgery without complications.
Gastric bypass surgery is an effective weight-loss option for patients who are morbidly obese, but obese patients have a greater risk of complications from abdominal surgery than patients who are not obese. To lower those risks, the standard of practice calls for patients to reduce their weight by 5 to 10 percent prior to gastric bypass. The EndoBarrier may help patients achieve this goal.
“If the device is proven to be safe and effective, it could potentially make surgery safer,” Nepomnayshy said.
Nepomnayshy also sees potential for the device to be used more broadly, for example, in obese people who want to avoid surgery or who are not candidates for gastric bypass. “While I do not think the device will be as effective as surgical weight management, it may ultimately provide patients with a less invasive, yet effective, treatment that will allow them to experience some of the health benefits associated with weight loss or diabetes resolution,” he said.
Gastric bypass has also been shown to eliminate type 2 diabetes in a high percentage of patients. This occurs as a primary effect and not as a result of weight loss. About 30 percent of morbidly obese patients have type 2 diabetes, Nepomnayshy said. Pending the results of the current trial, a larger study will be needed to assess the device's impact on diabetes.
Lahey's Center for Surgical Weight Loss is accredited as a Level 1a Bariatric Surgery Center by the American College of Surgeons' accreditation program. The center performs more than 150 weight loss surgeries each year, including gastric bypass and Lap-Band procedures.
The EndoBarrier is being developed by GI Dynamics Inc., based in Lexington, Mass., which is sponsoring the study.
About Lahey Clinic
Lahey Clinic, a physician-led, nonprofit group practice, is world-renowned for innovative technology, pioneering medical treatment, and leading-edge research. A teaching hospital of Tufts University School of Medicine, the Clinic provides quality health care in virtually every specialty and subspecialty, from primary care to cancer diagnosis and treatment to kidney and liver transplantation.
About GI Dynamics
GI Dynamics, founded in 2003, is leading the development of new, noninvasive approaches to treat obesity, type 2 diabetes and related diseases. The patented EndoBarrier™ technology is designed to line the small intestine for the first two feet after it leaves the stomach, resulting in weight loss and improved glycemic control. The company has raised $46 million in three rounds from top-tier investors such as Advanced Technology Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation and Polaris Venture Partners. GI Dynamics is led by an experienced management team and has assembled a scientific advisory board that includes internationally recognized leaders in bariatric surgery, gastroenterology, obesity medicine and endocrinology. (www.gidynamics.com)