Edwards Lifesciences cleared to expand device trial

01/29/2008 | Boston Globe (tiered subscription model), The

Edwards Lifesciences Corp. has received FDA clearance to include its Ascendra transapical delivery system in its current testing of the Sapien heart valve and to expand its trial sample size. "Incorporating Ascendra along with increasing the number of patients in the trial ... will better ensure that the trial endpoints are successfully met," the company's CEO said.

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