Medtronic has received CE mark for its direct aortic system, CoreValve, a transcatheter aortic valve implantation (TAVI) system approved for direct aortic and subclavian implantation.
The physicians will replace the diseased valve through a minimally invasive incision without stopping the heart or penetrating the heart’s ventricular wall.
Evaluations show the direct aortic approach demonstrates procedural success and overall survival rates on par with those from transfemoral and subclavian approaches.
The new approach is expected to allow easier manipulation and positioning of the valve due to the short distance between the access and implantation sites.
Medtronic senior vice president and Medtronic Structural Heart Business president John Liddicoat said the system is available in three sizes-26mm, 29mm and 31mm through three access routes, based on the original self-expanding platform that received CE Mark in 2007.
The system is in investigational use in the United States at present.