FDA approves Evolut PRO+

Evolut PRO+

The US Food and Drug Administration (FDA) has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds off the proven self-expanding, supra-annular Evolut TAVI platform. The press release adds that the Evolut PRO+ includes four valve sizes with an external pericardial tissue wrap that provides advanced sealing for the largest indicated patient treatment range and the lowest delivery profile currently on the market. Last month, the FDA approved the Evolut TAVI device for the management of low-risk patients with severe aortic stenosis.

The Evolut PRO+, according to the press release, can treat the broadest annulus range and offers the lowest delivery profile on the market (the 23mm, 26mm and 29mm valves can treat vessels down to 5mm). It features four valve sizes—including the 34 mm (treats vessels down to 6mm) with an external tissue wrap and an integrated, inline sheath, allowing physicians to treat patients with a range of anatomical variations. Consistent with the Evolut platform design, the PRO+ valve is designed with a self-expanding nitinol frame that conforms to the native annulus with consistent radial force and advanced sealing. The valve incorporates an outer porcine pericardial tissue wrap that adds surface area contact and tissue interaction between the valve and the native aortic annulus to help potentially reduce incidences of paravalvular leaks.

Pieter Kappetein, vice president and chief medical officer for the Structural Heart and Cardiac Surgery businesses, which are part of the Cardiac and Vascular Group at Medtronic, says: “We anticipate the Evolut PRO+ TAVI system will help heart teams fine-tune their TAVI procedures, further building on the consistent and reliable outcomes that they have come to expect from the Evolut TAVI platform—including positive haemodynamic outcomes in part, due to its supra-annular valve design—which we continue to see with the Evolut platform across large-scale, randomized clinical trials. In addition to a decrease in profile for the core sizes to help minimise burden on the vessels during the procedure, the Evolut PRO+ TAVI system gives heart teams a familiar technology that has been fine-tuned to help drive excellent patient outcomes.”

The Evolut TAVI platform, including the Evolut R, EvolutTPRO and Evolut PRO+ TAVI systems, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the USA.


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