Edwards Lifesciences Corp. (EW), a pioneer in artificial heart valves, fell the most in three years in New York trading after U.S. regulators said insertion of the company’s new valve poses a high risk of stroke and death.
The shares of Irvine, California-based Edwards declined $4.99, or 6.6 percent, to $70.88 at 4 p.m. in New York Stock Exchange composite trading. They dropped as much as 11 percent to $67.50, the biggest intraday decline since August 2008.
The U.S. Centers for Medicare and Medicaid Services will review reimbursement rules for Edwards’s heart valve replacement product, the agency said late yesterday on its website. The center said it’s aware of high rates of stroke and death by patients who have received the valves, a procedure that’s mostly performed in top academic medical centers.
“This limited experience in the U.S. raises the question of generalizability of the existing evidence base to more ‘real world’ settings,” the agency said.
At issue is the insertion of the valves through a procedure called transcatheter aortic valve replacement, or implantation. The procedure is meant to treat aortic stenosis, a condition where a valve in the heart doesn’t completely close as it pumps blood. The FDA has yet to approve the valve product itself, according to Medicare.
Medicare pays for drugs and devices that have been approved by the U.S. Food and Drug Administration. A national coverage analysis means the agency has decided to review conditions for a drug or device’s use and payment.
“The NCD draft is just entering the public comment period, and we expect it to evolve as the societies, regulators and other stakeholders provide their input on the important details,” Edwards said in an e-mailed statement.
An adverse decision by the government would limit use of the Edwards product, Michael Weinstein, an analyst at JPMorgan Chase & Co. said in a note to clients today. “Essentially, TAVI is going to be a procedure done by the best doctors and only on the worst patients.”
Edwards has been making artificial heart valves since 1960.
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