Medtronic Wins FDA Approval Of Next-Gen TAVR System For Aortic Stenosis

The FDA has approved Medtronic plc's MDT Evolut FX TAVR system, a self-expanding transcatheter aortic valve replacement (TAVR) system.
The Evolut FX system incorporates the same supra-annular valve design with hemodynamic performance superior to surgical aortic valve replacement (SAVR) across large-scale, randomized clinical trials.
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The fourth-generation Evolut technology is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant.
Like its predecessor (Evolut PRO+), the newest system includes four valve sizes.
The Evolut TAVR platform (including the Evolut R, Evolut PRO, Evolut PRO+, and Evolut FX) is indicated for symptomatic severe aortic stenosis patients across all risk categories.
The U.S. Limited commercial release is planned for the fall, with a full launch anticipated in early 2022.
Related content: Benzinga's Full FDA Calendar.
Price Action: MDT shares are up 2.77% at $132.04 during the market session on the last check Tuesday.