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www.fdanews.com/articles/202609-medtronic-earns-ce-mark-for-transcatheter-aortic-valve-implant-system
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Medtronic Earns CE Mark for Transcatheter Aortic Valve Implant System

May 4, 2021

Medtronic has been granted CE mark certification for its Evolut PRO+ Transcatheter Aortic Valve Implantation (TAVI) system.

The system has been cleared in Europe in four valve sizes (23, 26, 29 and 34 mm) and is designed with an integrated inline sheath that lets physicians treat patients with a variety of anatomical variations.

The valve features a self-expanding nitinol frame that provides consistent radial force and advanced sealing. Nitinol is an alloy of nickel and titanium that is superelastic and has “shape memory” properties that enable it to return to its original shape.

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