FDA Approves Edwards Sapien Heart ValveWednesday, November 2, 2011
Irvine-based Edwards Lifesciences Corp. said today that the Food and Drug Administration has approved its Edwards Sapien less-invasive heart valve.
Edwards Sapien is considered one of the largest advances in the heart valve market, with the potential to open up the market to for patients who would otherwise be unable to have major surgery.
The valve is intended to treat severe symptomatic aortic stenosis, or a narrowing of the arteries. It is delivered through a catheter inserted through the femoral artery.
Sapien has been sold in Europe since 2007. For the third quarter, it accounted for $82.6 million in sales, a 69% increase from the year-ago period.
Edwards has total annual revenue of about $1.5 billion.
Based on Edwards Sapien’s approval, about 20,000 new patients will be eligible to receive a heart valve yearly, said Jan Wald, a medical device analyst with Morgan, Keegan & Co. in Memphis, in published reports.