Reuters, May 3, 2012

The U.S. Medicare and Medicaid federal health insurance programs will cover the non-invasive Sapien heart valve replacement system from Edwards Lifesciences Corp, U.S. regulators said on Tuesday. The Sapien system is meant for patients deemed too sick to have heart valve replacement using more traditional open-heart surgery. The U.S. Food and Drug Administration approved the Sapien valve, which is estimated to cost about $30,000, in November. The U.S. Centers for Medicare & Medicaid Services (CMS) posted its reimbursement decision for the Transcatheter Aortic Valve Replacement (TAVR) system on Tuesday. The Sapien is widely considered to be one of the most important future growth drivers for Edwards.

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