St. Jude (STJ) Receives European CE Mark for Portico 23-mm Line

St. Jude Medical, Inc. (NYSE: STJ) has received European CE Mark approval for its 23 mm Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System. 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 valve is implanted through a small incision in the femoral artery (the main artery of the leg). The procedure uses a catheter placed percutaneously (through the skin) to deliver and position the valve in the heart and occurs while the heart continues to beat. This avoids the need to place the patient on cardiopulmonary bypass, a process in which a machine takes over heart and lung function during surgery.

The Portico device is the only approved transcatheter valve that can be completely 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. The valve was designed in collaboration with leading physicians to address limitations of current-generation devices by improving control and accuracy in positioning and placement of the valve, minimizing paravalvular leak (a common complication with first-generation transcatheter valves) and potentially reducing the need for the implantation of a permanent pacemaker after the procedure.

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