Medtronic CoreValve system gains CE mark for new subclavian approach to TAVI


Medtronic announced on 9 December 2010 that it has received CE mark for the Medtronic CoreValve system to be delivered through a novel approach, which would allow access through the subclavian artery located beneath the collar bone. As a result, thousands more patients in Europe with severe aortic stenosis may be eligible to receive transcatheter aortic valve implantation (TAVI).

Since 2007, the Medtronic CoreValve System has been implanted in more than 12,000 people in 34 countries. The Medtronic CoreValve System is currently limited to investigational use in the United States.

The CoreValve System is designed to provide a non-surgical aortic valve replacement option for patients with severe aortic stenosis who are at high or prohibitive risk for open-heart surgery. Transcatheter valves are typically implanted through the femoral artery in the leg. However, there are thousands of people whose femoral arteries are too narrow or are compromised due to disease.

“The subclavian approach will give physicians expanded access to care for a significant underserved subset of patients for whom femoral delivery is not possible or desirable. Given the sheer number of patients with severe aortic stenosis along with the aging population, the need for new approaches to valve replacement continues to increase,” said Neil Moat, The Royal Brompton Hospital in London, UK.