Medtronic CoreValve system gets CE mark for new direct aortic approach to TAVI


On 7 November, Medtronic announced it has received CE mark for its CoreValve system to be delivered using direct aortic access. According to the company, this is now the only transcatheter aortic valve implantation (TAVI) system approved for direct aortic and subclavian implantation. 

“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, cardiac surgeon at A De Gasperis Cardiology & Cardiac Surgery Department, Niguarda Ca’ Granda Hospital, 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 viable treatment alternative to the transfemoral (in the upper leg), transapical (through the wall of the heart), and subclavian artery (beneath the collar bone) approaches used by TAVI practitioners. In the procedure, physicians replace the diseased valve through a minimally invasive incision without stopping the heart or penetrating the heart’s ventricular wall. Early evaluations have shown the direct aortic approach demonstrates high procedural success rates and high overall survival rates that are similar to those from transfemoral and subclavian approaches. The new approach also may allow for easier manipulation and positioning of the valve due to the short distance from access site to implantation site.

“The direct aortic approach gives heart teams a new, minimally-invasive option as they seek to customise care for their patients,” said John Liddicoat, senior vice president of Medtronic and president of the Medtronic Structural Heart Business. “The CoreValve system is now available in three sizes (26mm, 29mm and 31mm) via three access routes, all based on the system’s original self-expanding platform that received CE mark in 2007.”

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