CE Mark for New Sizes of CoreValve® Evolut™R TAVI Offering

Medtronic has gained CE Mark approval for two new sizes of its CoreValve® Evolut™ R System. Now available in Europe in 26 mm and 29 mm sizes, the new larger valve sizes are delivered through a 14 French equivalent delivery system-the lowest profile on the market.

Background

Medtronic describes its CoreValve Evolut R as a next generation TAVI system, which allows small vessels to be accessed, and offers an extended sealing skirt intended to further promote valve sealing at the annulus. The self-expanding valve is claimed to advance performance and deliverability during TAVI procedures, while providing the option to recapture and reposition the implant during procedures.

The CoreValve Evolut R system, which consists of the valve itself 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). This provides a greater opportunity to treat patients with smaller vessels (down to 5.0 mm), which may minimize the risk of major vascular complications in some patients.

Medtronic says its Evolut R valve is also anatomically designed for optimal fit and sealing, while maintaining strong hemodynamic performance.

Physician comments

“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, M.D., consultant cardiologist, Royal Victoria Hospital, co-lead for the CoreValve Evolut R CE Mark study slated for presentation at ACC.15. “Expanding the Evolut R valve size range enables physicians to bring these important advances to a much broader range of patients.”

Company comments

“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 23 mm 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 programs that exemplify our safe and deliberate approach to expanding patient access.”

Source: Medtronic, plc

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