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Medical Devices / Regulatory Affairs / Submissions and Approvals

St. Jude Wins CE Mark for 25 mm Portico Transcatheter Aortic Heart Valve

Dec. 13, 2013

St. Jude Medical plans to launch its 25 mm Portico transcatheter aortic heart valve in the EU soon, following CE mark approval by European regulators. The valve is indicated for patients with severe aortic stenosis who are at high risk from conventional open heart valve replacement surgery.

As with other transcatheter aortic valve procedures, the Portico valve is inserted into the femoral artery and positioned while the heart continues to beat, avoiding the need to place the patient on a heart-lung bypass machine or to remove the diseased valve before replacing it. But unlike existing valve options, Portico can be resheathed and reinserted, if necessary, to improve the accuracy of placement and deployment, St. Jude says. This reduces the need for additional procedures in a high-risk patient population.

An older 23 mm version of the valve was CE-marked in November 2012. Neither size is available in the U.S.

According to the St. Paul, Minn., devicemaker, aortic stenosis is the third most common cardiovascular disease among patients in Western countries. — Lena Freund

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