Health Canada grants licence to Medtronic for its CoreValve Evolut R system

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CoreValve Evolut R
CoreValve Evolut R

Medtronic Canada has announced it has received a Health Canada licence for its recapturable, self-expanding CoreValve Evolut R System. A press release reports that the licence means that the transcatheter aortic valve implantation (TAVI) system is now the first and only recapturable and repositionable device available in Canada. It adds that the device can be used to treat severe aortic stenosis in patients who are at high or extreme risk for surgery.

Designed to treat patients with aortic stenosis, the CoreValve Evolut R System is built on the proven foundation and procedural success of the CoreValve system, which has been implanted in more than 75,000 patients in 60 countries.

The new system consists of the CoreValve Evolut R transcatheter valve and the EnVeo R delivery System, which features an InLine sheath that significantly reduces the profile to the lowest on the market (14Fr equivalent, less than 1/5inch). A smaller profile size provides a greater opportunity to treat an expanded patient population with smaller vessels (down to 5mm), through the preferred transfemoral access route, which may minimizse the risk of major vascular complications in some patients.

Based on the knowledge gained through the extensive experience with the CoreValve system, the Evolut R is optimised to increase conformability and sealing at the annulus, while maintaining supra-annular valve positioning for improved blood flow and haemodynamic performance. An extended sealing skirt on the 26mm and 29mm valve sizes is intended to further promote valve sealing at the annulus.

Michael Blackwell, senior director of director of the CardioVascular Group at Medtronic Canada, says: “Obtaining a Health Canada licence for Evolut R marks a significant milestone for Medtronic and TAVI, and ushers in a new era in transcatheter aortic valves with advanced, recapturable capabilities. This licence is an outcome of our commitment to building a market‑leading innovation pipeline in the transcatheter space, and we look forward to supporting heart teams as they look to next-generation technologies that optimise valve performance for a broad range of patients.”