Winning a first-of-its-kind expanded use from FDA, Medtronic beat Edwards Lifesciences to the punch in the ongoing race for domination in the transcatheter aortic valve replacement (TAVR) market. Earlier this week, FDA said yes to approving the use of Medtronic’s CoreValve for valve-in-valve replacement. The indication is for patients who need a second tissue aortic valve replacement due to failure of a previously implanted valve.
FDA initially approved the self-expanding CoreValve System in January 2014 for use in high-risk patients with aortic stenosis (narrowing of the aortic valve). This patient population is generally older, and they fall into the “high-risk” or “extreme risk” category for traditional (open) aortic valve replacement.
In an FDA press release, William Maisel, MD, deputy center director for science and chief scientist at CDRH, called the agency’s decision an “important expansion of the authorized use of the transcatheter aortic valve replacement technology”. FDA reviewed data from 143 U.S. clinical trial participants as part of the process for evaluating the safety and efficacy of CoreValve for the valve-in-valve replacement indication.
And in another win this week, Medtronic gained approval for the CoreValve System in Japan (also for patients with severe aortic stenosis and unable to undergo traditional surgery).
For the foreseeable future, Edwards and Medtronic will continue to lead the global TAVR market, which was worth more than an estimated $1 billion in 2013. The market is expected to surpass $3 billion by 2020, according to a recent report released by research and consulting firm GlobalData earlier this month.