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 key clinical and regulatory advancements have been announced by a host of additional potential competitors looking to further improve outcomes and expand the eligible patient population over first- and second-generation TAVR devices
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?