Medtronic announces results of CoreValve trial, gives FDA update

|About: Medtronic plc (MDT)|By:, SA News Editor

After trading near the flat line for most of the session, Medtronic (MDT +1.4%) rallies as the company reports results from a U.S. pivotal trial of CoreValve.

MDT says CoreValve reduced the rate of death or major stroke for "patients who were considered too ill of frail to have their aortic valves replaced through traditional open-heart surgery" — the results were "highly" statistically significant and the trial met both its primary and secondary endpoints.

Additionally, the company says "the FDA has determined it has sufficient information to evaluate the safety and efficacy of the CoreValve System for [the extreme risk] patient group without the need for an external expert panel."

MDT expects approval for this group by the end of next year. (PR)