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Edwards gets conditional FDA nod for revised heart product trial

Tue Jan 29, 2008 6:55am EST

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Jan 29 (Reuters) - Edwards Lifesciences Corp (EW.N) said it received conditional approval from U.S. health regulators for revised design of a key trial testing the company's product in open-heart valve surgery.

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The trial of the heart valve technology called SAPIEN will now include the Ascendra valve replacement system and have a sample size of 1,040 patients, compared with 600 patients earlier, the maker of heart valve replacements said. (Reporting by Varsha Tickoo in Bangalore; Editing by Himani Sarkar)

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