Transcatheter Aortic Valve Gains CE Mark for Subclavian Access


December 10, 2010

December 10, 2010 – European CE mark approval has been granted so the Medtronic CoreValve transcatheter aortic valve replacement system can be delivered through the subclavian artery, located beneath the collar bone.

As a result of this new vascular access point, thousands more patients in Europe with severe aortic stenosis may be eligible to receive transcatheter aortic valve implantation (TAVI). Since 2007, the CoreValve system has been implanted in more than 12,000 people in 34 countries. It was previously only available through femoral access delivery.

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. 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, MBBS, MS, FRCS and consultant cardiac surgeon at The Royal Brompton Hospital in London.

Medtronic will begin training physicians on the subclavian technique in the coming weeks.

The valve is currently limited to investigational use in the United States.

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