Regulatory Focus™ > News Articles > Pilot Trial Skipped, Pivotal Trials Ready for Diabetes Device

Pilot Trial Skipped, Pivotal Trials Ready for Diabetes Device

Posted 27 August 2012 | By

The US Food and Drug Administration (FDA) is allowing GI Dynamics (GID) to move directly into pivotal clinical trials with its diabetes treatment device, according to a story from Mass High Tech.

President and CEO Stuart Randle told the website his company's device, Endobarrier, has been approved and is marketed already in Australia, Chile and several European countries. He said Endobarrier has completed 13 clinical trials around the world, giving FDA "confidence" in letting GID skip the pilot trial usually required for medical devices.

According to a statement byGID, the Endobarrier lines a portion of the intestinal wall and helps regulate the absorption of sugar into the bloodstream. Randle said the device is swallowed, eliminating dangerous surgery.

Randle told Mass High Tech previous trials have targeted obese diabetic patients, but the company wants to expand to include all patients with diabetes. The clinical trial is expected to begin before the end of the year.

Read more:

Mass High Tech - GIDynamics gets FDA OK for clinical trial

GI Dynamics - GI Dynamics,Inc. Announces FDA Conditional Approval for Pivotal Clinical Trial of theEndoBarrier

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