GI Dynamics Inc. won another CE Mark for its EndoBarrier anti-obesity and Type II diabetes device, this time for a 12-month indication.
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.
GI Dynamics won a CE Mark for the device late last year, covering six months of treatment; the device is also cleared in the European Union for a three-month course of treatment.
A month after signing a distribution deal in the United Kingdom, the company is rolling out the EndoBarrier there. CEO Stuart Randle said GI Dynamics is planning for a rollout of the device on the Continent this year.
“We look forward to training additional centers in Europe over the next year and making the EndoBarrier available more broadly in the near future,” Randle said in prepared remarks.