St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced it 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.
"The ability to completely resheath, reposition or retrieve the Portico valve is an important improvement over previous-generation transcatheter valves," said Dr. Ganesh Manoharan of Royal Victoria Hospital in Belfast, U.K. "This is particularly helpful in ensuring accurate placement of the valve and minimizing complications for this high risk population."
Featuring leaflets made of bovine pericardial tissue attached to a self-expanding stent, the Portico valve was designed to help increase physician control and placement accuracy during deployment of the valve.
"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," said Frank J. Callaghan, president of the St. Jude Medical Cardiovascular and Ablation Technologies Division. "It also represents a key milestone for St. Jude Medical's transcatheter heart valve program, and exemplifies our focus on developing technologies that advance the practice of medicine."
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, sponsored by the Cardiovascular Research Foundation. 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).
St. Jude Medical also intends to begin a European study of the 25 mm valve to support CE Mark approval before the end of the year.