US FDA approved Medtronic PLC's CoreValve Evolut transcatheter aortic to treat patients at intermediate risk for open-heart surgery just four months after the company filed the pre-market approval supplement for the expanded indication, the company announced July 10.
The CoreValve Evolut platform includes CoreValve, CoreValve Evolut R and the CoreValve Evolut PRO transcatheter valves. FDA approved CoreValve Evolut Pro in March and the company expects to launch Evolut Pro in the US by fall 2017
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