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Direct Flow Medical Secures CE Mark For TAVR Device

Direct Flow Medical announced Jan. 28 the receipt of a CE mark for its transcatheter aortic heart valve system, to compete with Edwards, Medtronic among others in burgeoning market.

Direct Flow Medical Inc. announced the receipt of a CE mark for its transcatheter aortic heart valve system Jan. 28.

The CE mark is based on results from 33 patients in the DISCOVER trial, in which 97 percent of subjects experienced no or mild aortic regurgitation. The DISCOVER trial also showed a 97 percent rate of freedom from all-cause mortality after 30 days; the firm’s first-in-man data showed a four-year survival rate of 54 percent

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