The FDA will review a heart valve that can be implanted without major surgery this week. The valve is created by Medtronic competitor Edwards Lifesciences.
Test results released by Edwards Lifesciences found that its new Sapien heart-valve works for some patients who are too frail to undergo traditional open heart surgery for narrowing aortic valves. However, the FDA cited some concerns over stroke risks, officials said.
In a preliminary trial, Edwards Lifesciences found that 8 percent of patients who received the Sapien device suffered a stroke -- twice the number of stroke victims found in the control group.
The FDA will convene a panel of outside doctors on Wednesday to review Edwards application and preliminary findings.
The review is of interest to Fridley-based Medtronic, which began clinical trials on a competing product about eight months ago. About 300,000 patients suffer from "aortic valve stenosis" or valve narrowing, making the quest for a successful product potentially lucrative.
Dee DePass • 612-673-7725
