Subclavian Approach With Medtronic CoreValve TAVI System Approved in Europe

December 9, 2010—Medtronic, Inc. (Minneapolis, MN) announced it has received CE Mark approval for subclavian artery delivery of the Medtronic CoreValve transcatheter aortic valve implantation system. Medtronic stated that the company will begin training physicians on the subclavian technique in the coming weeks.

The CoreValve System is designed to provide a nonsurgical aortic valve replacement option for patients with severe aortic stenosis who are at high or prohibitive risk for open heart surgery. The device is not commercially available in the United States.

“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,” commented Neil Moat, MBBS. “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.”