EU approves Medtronic's CoreValve for direct aortic access

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Medtronic has received CE m ark for its CoreValve system to be delivered using direct aortic access.

The system is now the only transcatheter aortic valve implantation (TAVI) system approved for direct aortic and subclavian implantation in Europe. CoreValve is currently limited to investigational use in the U.S.

“For patients at high risk for surgery, transcatheter aortic valve implantation has become an established alternative for aortic valve replacement, yet we have found that some patients are considered unsuitable because of small vessel size,” said Giuseppe Bruschi, MD, cardiac surgeon at Niguarda Ca’ Granda Hospital in Milan, Italy. “For these patients, the direct aortic approach provides a minimally invasive surgical option.”

This new approach will provide severe aortic stenosis patients with a treatment alternative to the transfemoral, transapical and subclavian artery approaches used by TAVI practitioners. During the procedure, physicians replace the diseased valve through a minimally invasive incision without stopping the heart or penetrating the heart’s ventricular wall.

The CoreValve System is now available in three sizes (26mm, 29mm and 31mm) via three access routes, based on the system’s original self-expanding platform that received CE mark in 2007.