FRIDLEY (dpa-AFX) - Medtronic Inc. (MDT) said Tuesday it has completed patient enrollment in the extreme risk study in its CoreValve U.S. Pivotal Trial. The medical devices company also won approval from the U.S. Food and Drug Administration for an extended investigation, under the FDA's Continued Access Policy, to continue enrolling extreme risk patients under a Continued Access Study protocol. According to Medtronic, in the Trial's second study evaluating high risk patients for aortic valve surgery, enrollment completion is anticipated later this year. The CoreValve U.S. Trial is evaluating the self-expanding CoreValve System in three sizes (26mm, 29mm and 31mm) and using three delivery access routes: the through the transfemoral artery in the upper leg, through the subclavian artery beneath the collar bone, and directly through the aorta via a commonly-used, minimally invasive surgical incision. The CoreValve System is designed to replace diseased aortic valves without open-heart surgery. Worldwide, about 300,000 people have been diagnosed with this condition, and nearly one-third of these patients are deemed at too high a risk for open-heart surgery1. The company said that overall, the trial is enrolling over 1,500 patients, with about two-thirds of patients in the high risk study. Patients in the extreme risk study are being evaluated against a performance goal derived from contemporary studies. Patients in the high risk group are being randomized one-to-one to either transcatheter aortic valve implantation with the CoreValve System, or to surgical aortic valve replacement.
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