Medtronic has received CE mark for its CoreValve System to be delivered through a new approach, which would allow access through the subclavian artery located beneath the collar bone.
Medtronic CoreValve System is designed to provide a non-surgical aortic valve replacement option for patients with severe aortic stenosis who are at high or prohibitive risk for open-heart surgery.
As a result of CE mark, thousands more patients in Europe with severe aortic stenosis may be eligible to receive transcatheter aortic valve implantation (TAVI) which are typically implanted through the femoral artery in the leg.
The Royal Brompton Hospital in London consultant cardiac surgeon Neil Moat said the subclavian approach will give physicians expanded access to care for an 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," Moat said.
The Medtronic CoreValve System is currently limited to investigational use in the US.