Medtronic has launched the Evolut PRO+ transcatheter aortic valve replacement (TAVR) System in the US, following the receipt of approval from the US Food and Drug Administration (FDA).
Based on the company’s self-expanding, supra-annular Evolut TAVR platform, which recently obtained FDA approval for symptomatic severe aortic stenosis treatment in patients at low surgical mortality risk, the device is indicated to treat patients with symptomatic severe aortic stenosis.
The Evolut PRO+ TAVR System comes with four valve sizes and an external pericardial tissue wrap to provide sealing for the highest indicated treatment range, as well as the lowest delivery profile on the market.
Furthermore, the device features an inline sheath to treat patients with multiple anatomical variations. It consists of a self-expanding nitinol frame, which can conform to the native annulus.
The valve has an outer porcine pericardial tissue wrap to facilitate better surface area contact and tissue interaction with the aortic annulus to minimise incidences of paravalvular leaks.
Medtronic structural heart and cardiac surgery businesses vice-president and chief medical officer Pieter Kappetein said: “We anticipate the Evolut PRO+ TAVR System will help heart teams fine-tune their TAVR procedures, further building on the consistent and reliable outcomes that they have come to expect from the Evolut TAVR platform, including positive hemodynamic outcomes in part, due to its supra-annular valve design, which we continue to see with the Evolut platform across large-scale, randomised clinical trials.”
Severe aortic stenosis is a result of stiff and thickened aortic valve leaflets that have difficulty in opening and closing. If left untreated, symptomatic severe aortic stenosis can lead to heart failure within two years.
Medtronic offers Evolut TAVR platform, which comprises Evolut R, Evolut PRO and Evolut PRO+ TAVR Systems, to treat the condition across all risk categories in the US.