Medtronic Wins Nod for TAVR System Ahead of TCT 2019

Medtronic has won a nod from FDA for the Evolut PRO+ TAVR System – a next-generation transcatheter aortic valve replacement system. The agency’s approval of the device comes just a few days before – TCT 2019. Plans call for the Dublin-based company to launch the product, which builds off the self-expanding, supra-annular Evolut TAVR platform. The Evolut PRO+ TAVR System can treat the broadest annulus range and offers the lowest delivery profile on the market (the 23, 26- and 29-mm valves can treat vessels down to 5.0 mm). Evolut PRO+ features four-valve sizes – including the 34 mm (treats vessels down to 6.0 mm) – with an external tissue wrap and an integrated, inline sheath, allowing physicians to treat patients with a range of anatomical variations. 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. In a release, Pieter Kappetein, MD, PhD, VP, and CMO for the Structural Heart and Cardiac Surgery businesses at Medtronic said, “We anticipate the Evolut PRO+ TAVR System will help heart teams fine-tune their TAVR procedures, further building on the con...
Source: MDDI - Category: Medical Devices Authors: Tags: Cardiovascular Source Type: news