Medtronic has secured approval from the US Food and Drug Administration (FDA) for its next-generation, self-expanding transcatheter aortic valve replacement (TAVR) system called Evolut FX TAVR system to treat symptomatic severe aortic stenosis.
The company has designed the new TAVR system to deliver improved precision and control across the procedure, in addition to maintaining the hemodynamic (blood flow) and durability benefits of the Evolut platform.
Medtronic’s Evolut FX system features the same supra-annular valve design, which has demonstrated hemodynamic performance superior to surgical aortic valve replacement (SAVR) across large-scale, randomised clinical trials.
The fourth-generation Evolut technology is integrated with gold markers built into the frame to offer implanters with direct visualisation of depth and valve leaflet location during implant.
The Evolut FX system also features a redesigned catheter tip for a smoother insertion profile and a more flexible delivery system that facilitates 360-degree freedom of motion with a stable and predictable deployment.
Similar to its predecessor Evolut PRO+, the new system consists of four valve sizes for the largest indicated patient treatment range.
Medtronic cardiovascular portfolio’s coronary and renal denervation business and the structural heart and aortic business vice president chief medical officer Dr Jeffrey Popma said: “The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix, and advanced valve sealing to help minimise paravalvular leak.
“Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualisation capabilities for orientation and depth.”
The Evolut TAVR platform, which includes the Evolut R, Evolut PRO, Evolut PRO+ and Evolut FX, is indicated for symptomatic severe aortic stenosis patients across all risk categories in the US.
The company is planning the limited commercial release of the new system this fall and aims to fully launch in early 2022.
