Nov 19 St. Jude Medical Inc said on
Monday that it had received approval from European health
regulators to market its transcatheter aortic heart valve.
The 23mm (0.9-inch) device, called Portico, was approved for
transfemoral delivery. That means the valve is implanted using a
catheter that is threaded through the femoral artery, the main
artery in the leg, sparing patients the need for open-heart
The product was designed for patients with severe aortic
stenosis who are considered to be too high-risk for open-heart
surgery. This disease keeps the aortic valve from opening fully,
decreasing blood flow from the heart.
The St. Jude device would compete in Europe with similar
products made by Edwards Lifesciences Corp and Medtronic
St. Jude said it intended to initiate a European study of a
25mm version of the valve to support European approval before
the end of the year.