Medtronic eyes faster FDA nod as CoreValve aces pivotal study

Thanks to strong pivotal results, Medtronic is moving up its expected U.S. launch of CoreValve.--Courtesy of Medtronic

Medtronic ($MDT) is moving up its expected U.S. launch date for CoreValve, posting impressive safety and efficacy results as it looks to contend with market leader Edwards Lifesciences ($EW) on its home turf.

In one-year data presented at this week's Transcatheter Cardiovascular Therapeutics conference, aortic stenosis patients treated with Medtronic's replacement valve had a 25.5% rate of death or major stroke, far below the 43% seen with standard therapy. And in patients at extreme risk, the rate of major stroke was just 1.8%, among the lowest ever seen for those patients, the company said.

Those results convinced the FDA that CoreValve doesn't need to go through an advisory committee before being considered for approval in extreme-risk patients, Medtronic said, and the company is moving up its planned launch date from mid-2014 to sometime in the first quarter of next year. The agency will evaluate CoreValve for lower-risk patients separately.

Medtronic's accelerated launch is undoubtedly bad news for Edwards, which has had a U.S. monopoly on transcatheter aortic valve replacements since the first-generation Sapien won FDA approval in 2011. The California devicemaker has been beset by investor disappointment and mounting competition all year, facing doubts over a slow uptake in Sapien sales and watching the European market crowd with offerings from Medtronic, 2013 Fierce 15 winner JenaValve and, as of this week, Boston Scientific ($BSX).

Despite Edwards' head start and market saturation, Medtronic believes CoreValve's stroke-preventing pedigree will help it snag a sizable market share once it makes U.S. landfall, and co-principal investigator Jeffrey Popma said the nation's cardiologists will appreciate the device's benefits.

"The fact that nearly three-quarters of patients were alive and free of strokes at one year is remarkable, given the complex medical conditions and extreme frailty of this population," Popma said in a statement. "Not only do the results meet the CoreValve study's safety and efficacy endpoints for patients at extreme risk for surgery, but the positive clinical outcomes and low complication rates set a high standard for what transcatheter valves can achieve."

About 300,000 people around the world suffer from severe aortic stenosis, about one-third of whom are ineligible for open-heart surgery and thus indicated for transfemoral systems like CoreValve. Since winning a CE mark in 2007, Medtronic's device has been implanted in more than 45,000 patients overseas.

- read the announcement

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