Medtronic has announced CE mark for the 26mm and 29mm sizes of the CoreValve Evolut R System, a self-expanding valve that advances performance and deliverability during transcatheter aortic valve implantation (TAVI), while providing the option to recapture and reposition the valve during procedures.
The new larger valve sizes are delivered through a 14 French equivalent delivery system (the lowest profile on the market) allowing small vessels to be accessed and offering an extended sealing skirt intended to further promote valve sealing at the annulus.
The 23mm, 26mm and 29mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo Delivery Catheter System are available in Europe and other countries that recognise the CE mark. It is not approved for commercial use in the USA, where it is currently undergoing clinical trials.
“The clinical experience with the Evolut R system has been exceptional. The system’s optimal positioning and delivery of the valve are essential to achieve the very best clinical results in TAVI. Evolut R’s low profile, positioning accuracy and enhanced sealing, all supported with the option to recapture and reposition during implantation, are a significant advance for transcatheter therapy,” said Ganesh Manoharan, consultant cardiologist, Royal Victoria Hospital, Belfast, UK, co-lead for the CoreValve Evolut R CE mark study slated for presentation at the American College of Cardiology Scientific Session 2015. “Expanding the Evolut R valve size range enables physicians to bring these important advances to a much broader range of patients.”
The system, which consists of the CoreValve Evolut R transcatheter aortic valve and the EnVeo R Delivery Catheter System, is designed for first-time positioning accuracy and also offers a new InLine sheath that significantly reduces the profile to the lowest on the market (14 Fr equivalent, less than 1/5 inch); a smaller profile size provides a greater opportunity to treat patients with smaller vessels (down to 5mm), which may minimise the risk of major vascular complications in some patients. Medtronic also says that the Evolut R valve is anatomically designed for optimal fit and sealing, while maintaining strong haemodynamic performance.
“Expanding patient access to the CoreValve Evolut R System has been a high priority, and we know the additional valve sizes have been highly anticipated by the physician community since the launch of the 23mm valve last fall,” said Rhonda Robb, vice president and general manager of Heart Valve Therapies at Medtronic. “Over the next several months we will support heart teams through training and education, imaging and patient evaluation programmes that exemplify our safe and deliberate approach to expanding patient access.”