GI Dynamics Inc.’s EndoBarrier gastrointestinal sleeve won Australian approval for treatment of type 2 diabetes and obesity.
The Lexington, Mass.-based company’s device is a plastic sleeve inserted endoscopically into the small intestine, where it slows the uptake of nutrients from food to induce weight loss and help control the symptoms of diabetes. The TGA approved EndoBarrier for up to 12 months of use.
“There is an urgent need for less invasive, yet effective treatments for type 2 diabetes and obesity,” Dr. Harry Frydenberg, director of the Epworth Centre for Bariatric Surgery, Victoria, Australia, said in prepared remarks. “We see many patients for whom existing pharmaceutical and lifestyle treatments are not effective in helping them manage their blood sugar levels or produce the weight loss they need.”
GI Dynamics won a CE Mark for the device in Dec., 2009, covering six months of treatment. The CE Mark was extended to 12 months of treatment in Oct., 2010.
A series of clinical studies in 2009 showed that patients treated with the EndoBarrier reduced their average blood glucose levels, lowered other diabetic factors including fasting blood glucose and weight and helped morbidly obese patients lose significant amounts of weight.
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