Edwards Lifesciences' heart valve wins widened approval
(Reuters) - Edwards Lifesciences Corp said U.S. health regulators widened the approved use of its Sapien artificial heart valve to include patients who are eligible for surgery but at high risk of serious surgical complications or death.
The U.S. Food and Drug Administration also approved delivering the heart valve by catheter transapically, or through the ribs.
The Sapien valve was approved last November only for patients deemed too sick to have heart valve replacement using more traditional open-heart surgery, and only for delivery through the femoral artery -- located in the leg.
The widened approved population and the second delivery approach could give a needed commercial boost to Sapien, whose sales have disappointed Wall Street investors.
"The indication expands the patient population to both younger, less-risky patients, as well as patients who have inadequate femoral access (common in female patients)," said RBC Capital Markets analyst Glenn Novarro.
Novarro said he believed rib access could be used relatively soon in about half of all Sapien procedures, at least until a new generation of Sapien, called "Sapien XT" is approved, likely in 2014.
The FDA widened approval to patients deemed eligible for surgery largely because of a clinical trial that showed death rates were similar among patients who received Sapien through its minimally invasive catheter and similar patients with aortic valve stenosis who received valve replacements through open-heart surgery.
But patients who received the Sapien transcatheter valve showed an increased risk for major vascular complications or stroke during the first month after the procedure.
Patients with aortic valve stenosis have heart valves that are partially clogged by calcium deposits, reducing blood flow and often leading to heart failure or cardiac arrest. Those with severe stenosis must have a heart valve replacement to restore normal blood flow.
Shares of Edwards Lifesciences closed down 0.7 percent at $86.14 on Friday amid a sharp downturn for the broad stock market.
(Reporting by Balaji Sridharan in Bangalore; Editing by Roshni Menon, Kenneth Barry and Dan Grebler)
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