By Anjali Athavaley Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Centers for Medicare and Medicaid Services released guidelines late Tuesday detailing the conditions under which it would cover catheter-delivered heart valves marketed by Edwards Lifesciences Corp. (EW). Edwards, which received U.S. Food and Drug Administration approval for its Sapien valve last year, is the first to market such a device in the U.S. Companies like Medtronic Inc. (MDT) and St. Jude Medical Inc. (STJ) hope to launch similar devices here. But the lack of a government decision on reimbursement for catheter-delivered valves, which treats severe narrowing of the aortic valve, has been a hurdle for Edwards. Edwards Chief Executive Michael A. Mussallem said in February that pushback on reimbursement by regional Medicare contractors had hurt U.S. sales of Sapien. "It's positive to have a definitive reimbursement document available," said Raj Denhoy, an analyst at Jefferies & Co. Medicare's guidelines were similar to those proposed in February but included more stringent requirements for interventional cardiologists and hospitals without previous experience implanting catheter-delivered heart valves. The conditions did not require that clinical trials be designed for superiority. Some physicians had called the requirement, included in the proposed guidelines in February, restrictive. Edwards said in a statement Tuesday that it is reviewing CMS's conditions. "Given the comprehensive nature of the document, we expect to issue a comment when we have completed our analysis," the company said. Edwards shares fell a fraction to $84.75 post-market after closing up 2.2% in regular trading. The stock is down 1.8% in the last year. -By Anjali Athavaley, Dow Jones Newswires; 212-416-4912; anjali.athavaley@dowjones.com
