* Sapien for patients deemed too sick for open heart surgery
* Medicare coverage likely to accelerate sales
* Patients must be evaluated by two heart surgeons-CMS
WASHINGTON, May 1 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.