Medtronic has received CE marking for the self-expanding, recapturable and repositionable CoreValve Evolut R system to treat aortic stenosis patients who are at intermediate risk for open-heart surgery as determined by a heart team.
This makes the system the first transcatheter aortic valve implantation (TAVI) therapy to obtain an expanded indication in Europe for this patient population.
“The unique design of the self-expanding, supra-annular Evolut R system, coupled with its ability to be recaptured and repositioned for accurate valve placement, enables this device to be a viable treatment alternative for patients at intermediate surgical risk,” says Eberhard Grube, director of the Structural Heart Program at University Hospital in Bonn, Germany. “The…intermediate risk indication marks an important milestone for the industry as we look to safely expand TAVI access to younger and less sick patient populations.”
According to a company release, the new intermediate risk indication approval for system was based on positive clinical data from the Nordic Aortic Valve Intervention (NOTION) trial and from a subset analysis from the CoreValve US High Risk pivotal trial. Data from the NOTION trial showed that comparable clinical outcomes to surgery can be achieved by using CoreValve in patients who are good surgical candidates. Both datasets demonstrated excellent clinical performance for the CoreValve system with lower rates of all-cause mortality and major stroke compared to surgery, according to the release. Additionally, data showed low incidences of procedural complications and superior haemodynamic performance (blood flow) compared to surgery.
The CoreValve Evolut R system and the EnVeo R delivery catheter System are now approved for use in patients at extreme, high and intermediate surgical risk in Europe and other countries that recognise the CE mark. The CoreValve Evolut R system was US Food and Drug Administration-approved for commercial use in the USA in June 2015 for severe aortic stenosis patients who are at high or extreme risk for surgery.
The CoreValve Evolut R system is not currently approved to treat intermediate risk aortic stenosis patients in the USA.