A study of a Medtronic device showed that it was so effective that regulators will speed the process of getting it to the patients who need it.
Results of a late-stage clinical trial study of a Medtronic heart valve implant were presented Tuesday at a medical meeting in San Francisco. Reuters reports that results of the CoreValve study showed significantly lowered death and stroke rates in frail, elderly patients considered too ill for surgery.
The CoreValve implant is inserted through an artery, a less invasive alternative to open-heart surgery for patients with severe aortic stenosis.
Bloomberg reports the study was so convincing that it led regulators to decide the device won't need an advisory committee review. The Food and Drug Administration found the study provided enough information to determine if the valve should be sold in the U.S. That accelerates the process of getting the device to extreme-risk patients.
The rate of death or major stroke after one year was 25.5 percent, significantly below the study's goal of 43 percent. The study found 25.5 percent of patients died or suffered a stroke within a year compared with the 43 percent estimated before the trial started.
In a statement, Fridley-based Medtronic indicated it expects U.S. approval by April. CoreValve has been available in Europe since 2007.