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Medtronic notches milestones in CoreValve TAVI research, adds lower-risk patients

Thu, 08/30/2012 - 4:00pm
Mass Device

Medtech titan Medtronic closes enrollment in its U.S. pivotal trial for the CoreValve transcatheter aortic valve implantation system and lands FDA approval to expand a separate CoreValve trial to lower-risk patients.

Medtronic's CoreValve TAVI transcatheter aortic valve implantation device

Medical device heavyweight Medtronic (NYSE:MDT) notched some significant milestones in the ongoing clinical studies of the CoreValve transcatheter aortic valve implantation systems.

Medtronic announced this week that it had closed enrollment in the "high risk" arm of its U.S. pivotal trial and that the FDA granted the company approval to expand a separate CoreValve study to lower risk patients.

Medtronic hit its cap for the CoreValveR U.S. pivotal trial, having enrolled more than 1,500 patients with severe aortic stenosis who are at high or extreme risk for open-heart aortic valve surgery, according to a press release.

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