Medical Device Daily Staff Writer

Patients in Europe now have a non-surgical treatment option for Type 2 diabetes and obesity – a device known as the EndoBarrier from GI Dynamics (Lexington, Massachusetts).

According to the company, the device creates a barrier between food and the wall of the small intestine and thereby changes metabolic pathways by controlling how food moves through the digestive system. The effects are intended to be similar to gastric bypass surgery, but without the surgical procedure and hospital stay, GI says.

Physicians believe that preventing food from coming into contact with the intestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of a Roux-en-Y gastric bypass procedure without surgery, the company noted.

Jonathan Hartmann, VP of sales and marketing for GI Dynamics, told Medical Device Daily that the EndoBarrier offers "tremendous benefits" for patients who suffer from Type 2 diabetes and obesity. He said that patients who get the EndoBarrier are seeing an immediate improvement in their Type 2 diabetes, within the first week. The weight loss occurs over time, similarly to the results a patient could expect to see after having weight loss surgery. Hartmann added that patients are achieving a reduction in their HbA1c over roughly six months of about 2 points, which is "quite dramatic and very similar to what you see with gastric bypass."

"It's a very exciting time for us, these epidemics of Type 2 diabetes and obesity are growing rapidly around the world and we're just very excited now to have the opportunity to begin to help some of these people who are looking for a new alternative therapy," Hartmann said.

He said the patients the company has been studying who have had device out to six months have lost about 30% of their excess weight.

CE mark approval comes less than two months after the company reported favorable results of a European weight loss study published in the Annals of Surgery (Medical Device Daily, Nov. 3, 2009). Clinical trials involving more than 270 patients have demonstrated the significant weight loss and diabetes improvement achieved with the EndoBarrier Gastrointestinal Liner, GI said.

Hartmann said that receiving the CE mark for the EndoBarrier is "really exciting for us because it enables us to begin to commercialize the product in Europe," he said. "The prevalence of Type 2 diabetes in Europe is quite high and growing, just like it is in the United States." Hartmann said GI Dynamics plans to commercialize the device in Europe over the course of next year in a limited market release.

"Based on the clinical results to date, we believe the EndoBarrier, as part of a multidisciplinary approach, has the potential to change the treatment paradigm for Type 2 diabetes and weight problems," said Jan Willem Greve, MD, PhD, Gastrointestinal and Bariatric Surgery, Atrium Medical Center Parkstad (Heerlen, the Netherlands). "Due to its unique profile as a non-surgical and non-pharmaceutical treatment option, the EndoBarrier appears to provide the benefits of gastric bypass surgery without the complications and risks associated with surgery. Unlike traditional pharmaceutical approaches, this implantable device removes the burden of dose regimen compliance from the patient. We look forward to having access to the EndoBarrier as a new treatment option in our fight against these epidemics."

Hartmann emphasized that the EndoBarrier procedure is not permanent. The patient receives the device in about 30 minutes during an endoscopic procedure, and it can be removed just as quickly six months later without any permanent alteration to the patient's anatomy.

The company said that non-surgical therapeutics hold the potential to improve the patient's overall health, by providing the control necessary to institute lifestyle and nutritional improvements to maintain therapeutic effect, while being easily removed once the desired effect has been attained and lifestyle changes implemented.

GI says it is "defining" a new class of metabolic treatment options that fit between pharmaceutical regimens and surgery, called non-surgical therapeutics designed to eliminate or reduce the risks and side effects associated with pharmaceutical regimens as well as surgical options. This new class of treatment can be performed easily and quickly without any incisions, thus reducing patient anxiety and recuperative time, the company noted. Unlike traditional pharmaceutical approaches, GI said that non-surgical therapeutics remove the burden of dose regimen compliance from the patient.

"This European approval for six months of EndoBarrier therapy to treat Type 2 diabetes and obesity is another key milestone for GI Dynamics as we continue to prepare to launch the product in Europe," said Stuart Randle, CEO of GI Dynamics. "The growing body of clinical data demonstrates the EndoBarrier is well positioned to offer a meaningful, non-surgical approach to controlling diabetic factors and facilitating weight loss in patients suffering from the twin epidemics of Type 2 diabetes and obesity. With European marketing approval in hand, we look forward to initiating our commercialization plans in Europe in the first half of 2010."

As for bringing the device to the U.S., Hartmann told MDD that "We're continuing to have very positive discussions with the FDA and we're hoping to do it as soon as possible. For now, we're just going to focus on this European launch."

Type 2 diabetes affects an estimated 21 million Americans and 200 million people worldwide, the company noted. According to the World Health Organization, Type 2 diabetes comprises 90% of people with diabetes around the world, and is largely the result of excess body weight. The condition can also lead to significant health problems including cardiovascular disease, retinopathy, neuropathy and nephropathy.

GI Dynamics is also developing the EndoBarrier Flow Restrictor, which is designed to further enhance the effectiveness of the liner by doubling the amount of weight-loss that can be achieved using the liner alone (MDD, Aug. 28, 2009).

Founded in 2003, the company is backed by investors including Advanced Technology Ventures, Catalyst Health Ventures, Cutlass Capital, Domain Associates, Johnson & Johnson Development Corporation, and Polaris Venture Partners.

Amanda Pedersen, 229-471-4212;

amanda.pedersen@ahcmedia.com

Published  December 23, 2009