St Jude Medical wins EU approval for Portico heart valve

St Jude Medical has been granted European regulatory approval for its new Portico transcatheter valve, which is used in the treatment of severe aortic stenosis.

The new 23 mm transcatheter aortic heart valve and transfemoral delivery system has won CE Mark accreditation and is designed for patients considered inoperable or high risk for conventional open-heart valve replacement surgery.

It is implanted through a small incision in the femoral artery, while a catheter is placed percutaneously to deliver and position the valve in the heart while it continues to beat.

Portico is the only approved transcatheter valve that can be completely resheathed, repositioned or retrieved, and its usage avoids the need to place the patient on cardiopulmonary bypass.

Frank Callaghan, president of the St Jude Medical cardiovascular and ablation technologies division, said: "The European approval of the Portico transcatheter valve signals the imminent availability of a next-generation treatment option that can help improve quality of life for patients with diseased or damaged aortic heart valves."

Last week, the company's Durata and Riata ST Optim implantable cardioverter defibrillator leads received an independent validation from the Population Health Research Institute.