St Jude Medical has received European CE mark approval for its 23mm Portico Transcatheter Aortic Heart Valve and Transfemoral Delivery System. The valve is designed for patients with severe aortic stenosis who are considered to be inoperable or high risk for conventional open-heart valve replacement surgery.
St Jude states that “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 ability to completely resheath, reposition or retrieve the Portico valve is an important improvement over previous-generation transcatheter valves,” said Ganesh Manoharan of Royal Victoria Hospital in Belfast, UK. “This is particularly helpful in ensuring accurate placement of the valve and minimising complications for this high risk population.”
Manoharan recently presented the first-in-human 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).
The valve, made of bovine pericardial tissue (leaflets), 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, minimising paravalvular leak and potentially reducing the need for the implantation of a permanent pacemaker after the procedure.
“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 programme, and exemplifies our focus on developing technologies that advance the practice of medicine.”
St Jude Medical announced that it intends to begin a European study of the 25mm valve to support CE mark approval before the end of the year.