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, which is threaded to the diseased heart through an incision in the groin or ribs via the femoral artery, 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.
"We believe the final national coverage decision will help clarify the reimbursement confusion that has existed since Sapien was launched in the U.S. last November, which should help accelerate Sapien sales in the U.S.," Wells Fargo Securities analyst Larry Biegelsen said in a research note.
In pivotal clinical trials, the Sapien valve system led to a slightly lower death rate and dramatically shorter recovery times and hospital stays than chest cracking, open heart surgery. But the TAVR also led to significantly higher incidence of stroke, potentially making surgery preferable for some, especially younger, stronger patients.
Among the conditions that must be met to receive reimbursement, CMS said two heart surgeons must independently examine the patient to evaluate their suitability for open surgery versus a TAVR procedure.