St. Jude scores EU approval of Portico transcatheter aortic heart valve

St. Jude Medical has received European CE Mark approval for its 23 mm Portico transcatheter aortic heart valve and transfemoral delivery system, which is designed for patients with severe aortic stenosis who are considered to be inoperable or high risk for conventional open-heart valve replacement surgery.

The Portico device can be resheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site or retrieved before it is released from the delivery system, according to the St. Paul, Minn.-based company. 

St. Jude said it also intends to begin a European study of the 25 mm valve to support CE Mark approval before the end of the year.