Implantable Weight-Loss Device Receives CE Mark Approval

scale1Many patients who struggle with obesity consider gastric bypass surgery as an option for managing their weight. Procedures such as stomach stapling or lap-band surgery can help patients lose significant amounts of weight and improve the symptoms of obesity-related conditions like Type 2 diabetes. However, gastric bypass surgery also carries risks such as bleeding, gastrointestinal tract leaks, pulmonary embolism and death. Patients are cautioned to weigh their options carefully before choosing to undergo weight-loss surgery.

Now, MedGadget reports that patients in Europe will soon have an alternative therapeutic option for weight management. GI Dynamics of Lexington, Mass., has received European CE mark approval to commercialize a non-surgical device for the management of obesity and Type 2 diabetes. The EndoBarrier is implanted in the GI tract endoscopically to create a physical barrier between food and the gastrointestinal wall. Physicians believe that preventing food from coming in contact with the gastrointestinal wall may alter the activation of hormonal signals that originate in the intestine, thus mimicking the effects of Roux-en-Y (stomach stapling) surgery.

The EndoBarrier is designed to facilitate weight loss and help patients with Type 2 diabetes control their symptoms. Last month, interim data from an ongoing clinical trial was presented at the GASTRO 2009 conference. Researchers found that the EndoBarrier improved glycemic control and led to greater weight loss compared to a placebo. The device is not intended for permanent placement, and may only be used for a six-month period.

GI Dynamics is just one of several companies developing non-surgical options for patients dealing with obesity.  In October, OneMedPlace reported on the feverish race between Orexigen Therapeutics, Arena Pharmaceuticals and VIVUS to get their respective anti-obesity drugs on the market. On Tuesday, Arena announced that it had filed for U.S. regulatory approval to market its weight-loss drug candidate lorcaserin. Orexigen plans to file for approval next year.

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