Next-Generation CoreValve Device Receives CE Mark for Use in Intermediate-Risk Patients
Medtronic announced today that its CoreValve Evolut R transcatheter aortic valve replacement system has been approved for use in intermediate-risk patients with aortic stenosis in Europe, marking the first time a TAVR device has been cleared in this group.
“The highly anticipated 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," Eberhard Grube, MD (University Hospital Bonn, Germany), said in Medtronic press release.
Approval of this next-generation, self-expanding device—which is designed to be fully recapturable and repositionable—was based on results from a subset analysis of the high-risk cohort in the CoreValve US Pivotal Trial and from the NOTION trial. The latter trial showed that TAVR was comparable to surgery in lower-risk patients in terms of a composite of all-cause death, MI, or stroke.
CoreValve Evolut R is now approved for use in Europe for patients with intermediate, high, or extreme surgical risk. In the United States, the system has been approved for use only in patients with extreme or high risk.
The US Food and Drug Administration has given the go-ahead to two TAVR trials in low-risk patients, one evaluating CoreValve Evolut R and the other the Sapien 3 valve (Edwards Lifesciences). Both trials are currently enrolling patients.
Medtronic. Medtronic CoreValve Evolut R system first TAVI to receive CE mark for intermediate-risk aortic stenosis patients. http://newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=2191458. Published on: August 1, 2016. Accessed on: August 1, 2016.