US FDA Green-Lights Medtronic's CoreValve Evolut For Intermediate Risk

The approval, based on the results of the SURTAVI trial, comes a few months ahead of analysts' expectations and is welcome news for Medtronic in its effort to keep pace with TAVR leader Edwards in the US market.

Core Valve In Situ
CoreValve System in action. • Source: Medtronic PLC

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.

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