UPDATE 1-US Medicare to cover Edwards Sapien heart valve

Tue May 1, 2012 5:09pm EDT

* 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 (Reuters) - 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.

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Comments (1)
mrsmhm wrote:
This article misrepresents the Sapien valve and undersattes its effect on improving patient outcomes and survival because it starts out talking about patients too sick to receive open-heart surgery (and these are the only patients the valve is currently FDA-approved for), while later in the article, outcomes are compared to patients that GET open-heart surgery. There are two sub-sets of patients here – eligible for surgery and not – and the author is inconsistent in explaining the patient subgroups, reimbursement, treatments options, and outcomes associated with each treatment.

May 02, 2012 9:22am EDT  --  Report as abuse
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