Oct 29 (Reuters) - Medtronic Inc's CoreValve heart valve implant 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.
Patients with aortic stenosis have decreased blood flow from the heart because the valve does not open properly and face a poor prognosis without treatment.
Medtronic's CoreValve product is inserted into place through an artery, offering a less-invasive treatment alternative to traditional open-heart surgery in which the chest is cracked open and the heart valve replaced.
In the CoreValve Extreme Risk study, which was presented Tuesday at a 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 patients' average 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. The company, which funded the CoreValve study, expects to launch the product in the United States in 2014.
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Medtronic heart valve reduces death, stroke in study