St Jude Medical receives CE Mark approval for Portico transcatheter aortic heart valve and transfemoral delivery system
St Jude Medical has received European regulatory approval for its latest aortic heart valve and delivery system designed for patients with severe aortic stenosis.
The CE Mark covers its 23mm Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System and signals the continued advancement of next-generation treatment options available to patients in Europe with damaged aortic valves.
The Portico heart valve is currently 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. These capabilities allow physicians to optimise valve placement and minimise some of the risks associated with the procedure, for example, paravalvular leak, and potentially reducing the need for the implantation of a permanent pacemaker.
Since the heart continues to beat during the procedure, the Portico heart valve provides a viable option for high-risk aortic stenosis patients to receive treatment for a diseased or damaged heart valve
Frank J Callaghan, president of the St Jude Medical cardiovascular and ablation technologies division, explained: “Transcatheter aortic valve implantation, also referred to as transcatheter aortic valve replacement , is an innovative surgical option for patients considered high risk for conventional open-heart valve replacement surgery.
“The Portico heart valve is inserted via a catheter through the femoral artery in the leg and eliminates the need for open-heart surgery and cardiopulmonary bypass. Since the heart continues to beat during the procedure, the Portico heart valve provides a viable option for high-risk aortic stenosis patients to receive treatment for a diseased or damaged heart valve.
Dr Ganesh Manoharam of the Royal Victoria Hospital in Belfast has used the system and 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.”
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 system at the 24th Annual Transcatheter Cardiovascular Therapeutics (TCT) Scientific Symposium
St Jude Medical now intends to begin a European study of the 25mm valve to support CE Mark approval before the end of the year.