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European Approval of the St. Jude Medical Portico Transcatheter Aortic Heart Valve

St. Jude Medical’s new and innovative 23mm Portico™ Transcatheter Aortic Heart Valve and Transfemoral Delivery System has recently received European CE Mark approval.

The Portico™ heart valve has been designed for patients with severe aortic stenosis who are considered to be inoperable or a high risk for conventional open-heart valve replacement surgery.

Use of the valve avoids the need for a cardiopulmonary bypass as it is implanted through a small incision in the femoral artery, with a catheter being placed percutaneously to deliver and position the valve in the heart while the heart continues to beat.

The Portico heart valve is the only approved transcatheter valve that can be completely resheathed, repositioned at the implant site or retrieved before it is released from the delivery system.

It was designed in collaboration with leading physicians to address limitations of current-generation devices. Its design improves control and accuracy in positioning and placement, minimising paravalvular leak and potentially reducing the need for the implantation of a permanent pacemaker after the procedure.

On the device, Dr Ganesh Manoharan from the Royal Victoria Hospital, Belfast, said:

“The ability to completely resheath, reposition or retrieve the Portico valve is an important improvement over previous-generation transcatheter valves. This is particularly helpful in ensuring accurate placement of the valve and minimising complications for this high risk population.”

Dr Manoharan recently presented first-in-human (FIH) 12-month data demonstrating the safety and efficacy of the Portico transcatheter heart valve at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.

In the study there were no vascular complications, major strokes or deaths among study patients and no new pacemakers required. Clinical improvements that were noted at earlier follow-up intervals were sustained out to 12 months (including valve function).

For additional information about the Portico valve visit SJMPortico.com.

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