TAVR Market: Next-Generation Devices Seek To Optimize Outcomes

The market opportunity for TAVR is significant, with 2013 sales totaling $303.4 million in the US and $765 million outside the US, and those numbers are expected to grow to an estimated $1.29 billion and $1.63 billion, respectively, by 2018. Edwards and Medtronic dominate the worldwide market at present, but other companies are expected to make inroads with next-generation devices designed to optimize outcomes.

This year started off with a bang in the US cardiovascular device industry's bright spot, the emerging transcatheter aortic valve replacement (TAVR) market, with the earlier-than-expected January US Food and Drug Administration approval of Medtronic PLC's CoreValve system – a market monopolized by Edwards LifesciencesCorp. since November 2011 with its first-generation Sapien device. (See [A#2014700012].) While Medtronic has begun an aggressive US launch with the lower-profile (18 French [18F]) CoreValve, which leads the transfemoral TAVR segment in Europe, Edwards is anticipating US FDA approval of its next-generation, lower-profile (18F) Sapien XT device at any time.

Over the past few weeks, as Medtronic and Edwards gear up for a fight in the US market, several other...

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