By Susan Kelly
(Reuters) - Medtronic Inc's CoreValve heart valve implant significantly lowered death and stroke rates in frail, elderly patients with severe aortic stenosis who were considered too ill for surgery, according to data from a late-stage clinical trial.
Medtronic is preparing to launch the product in the United States, pending regulatory approval. It will compete with Edwards Lifesciences' Sapien heart valve, the only aortic valve replacement device currently on the U.S. market that can be implanted as an alternative to open-heart surgery.
Medtronic said it expects to launch the product in the United States for use in extreme-risk patients before its fiscal year ends in April 2014, noting that the U.S. Food and Drug Administration determined it has sufficient information to evaluate the device.
Shares of Medtronic closed up 1.5 percent on Tuesday, while those of rival heart valve maker Edwards Lifesciences fell 4.6 percent.
Patients with aortic stenosis have decreased blood flow from the heart because the valve does not open properly, and they face a poor prognosis without treatment.
The CoreValve implant is inserted through an artery, a less invasive alternative to traditional open-heart surgery in which the chest is cracked open and the heart valve replaced.
In the CoreValve Extreme Risk study, the results of which were presented Tuesday at the Transcatheter Cardiovascular Therapeutics medical meeting in San Francisco, the Medtronic device met its primary goals for reducing mortality and stroke.
The rate of death or major stroke after one year was 25.5 percent, significantly below the study's goal of 43 percent, in the 471 patients treated with the valve. The average patient age was 83 years.
"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," said Dr. Jeffrey Popma of Beth Israel Deaconess Medical Center in Boston, a co-principal investigator of the study.
CoreValve has been available in Europe since 2007 and competes with Edwards Lifesciences' transcatheter valve in that market.
The study presented on Tuesday provided a first look at U.S. data on Medtronic's CoreValve system.
Medtronic, which funded the study, said the FDA determined, after reviewing the study results, that it has enough information to evaluate the safety and effectiveness of the device in extreme-risk patients without the need to convene an expert panel for additional input.
"This is important as it accelerates the timeline for Medtronic's U.S. approval from late 2014 to (first-half) 2014 and is an obvious positive for Medtronic and negative for Edwards," J.P. Morgan analyst Michael Weinstein said in a note to clients.
FDA will conduct a separate review of the product for use in less-ill patients who are deemed high risk, Medtronic said. A group of high-risk patients is being evaluated in a separate clinical study.
(Reporting by Susan Kelly in Chicago; Editing by Tim Dobbyn and Leslie Adler)