Medtronic Gets FDA Approval For CoreValve Percutaneous Aortic Valve Replacement Trial
By Adam Pick on October 19, 2010
Interest in catheter-based technologies for heart valve repair and heart valve replacement continues to skyrocket.
As you have seen, we recently (i) reviewed new data for the SAPIEN aortic valve replacement and (ii) observed a MitraClip case for mitral valve repair. Recently, I learned that Medtronic, one of the leading heart valve manufacturers, received FDA approval for its investigational device exemption application. That means that Medtronic can conduct a patient trial to determine the safety and efficacy of its percutaneous CoreValve system for aortic valve replacement.
Aortic Stenosis – Narrowed Trileaflet Valve
Like the Edwards SAPIEN heart valve replacement, the CoreValve is a minimally invasive procedure intended for high-risk patients that suffer from aortic stenosis. The trial will enroll 1,200 patients at 40 clinical sites, according to Medtronic. Key metrics that the study will track are:
- Mortality rates one-year after implant
- Stroke incidence
- Days of hospitalization
The CoreValve heart valve replacement device received a CE mark in March, 2007 and has already been implanted in over 12,000 patients suffering from aortic stenosis across 34 countries. As you might recall, CoreValve was purchased by Medtronic for $700 million last year.
When I learn the details of the trial, I’ll make sure to pass it along to everybody. Again, this is a very exciting time for heart valve treatment.
Keep on tickin!