Medtronic's CoreValve Evolut R System Receives CE Mark Approval for 26- and 29-mm Sizes

February 2, 2015—Medtronic plc announced European CE Mark approval of the 26- and 29-mm sizes of its CoreValve Evolut R system, the company’s next-generation self-expanding valve for transcatheter aortic valve replacement (TAVR). The device provides the option to recapture and reposition the valve during procedures. The new, larger valve sizes are delivered through a 14-F–equivalent delivery system, allowing access to small vessels. An extended sealing skirt is intended to help promote valve sealing at the annulus.

The 23-, 26-, and 29-mm sizes of the CoreValve Evolut R TAVR device and the CoreValve EnVeo R delivery catheter system are available in Europe and other countries that recognize the CE Mark. It is not approved for commercial use in the United States, where it is currently undergoing clinical trials, advised Medtronic.

Ganesh Manoharan, MD, who is a consultant cardiologist at Royal Victoria Hospital in in Montreal, Quebec, Canada, and Co-Lead Investigator for the CoreValve Evolut R CE Mark study that is scheduled for presentation at ACC.15, commented in the company’s press release, “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 TAVR. 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. Expanding the Evolut R valve size range enables physicians to bring these important advances to a much broader range of patients.”

The system consists of the CoreValve Evolut R TAVR valve and the EnVeo R delivery catheter system. According to Medtronic, it 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-F equivalent); a smaller profile size provides a greater opportunity to treat patients with smaller vessels (down to 5 mm), which may minimize the risk of major vascular complications in some patients. The Evolut R valve is also anatomically designed for optimal fit and sealing while maintaining strong hemodynamic performance, stated Medtronic.