Medtronic (MDT) Receives FDA Nod for Evolut FX TAVR System
Zacks Investment Research | Aug 25, 2021 08:10AM ET
Medtronic (NYSE:MDT) plc MDT recently gained FDA approval for its Evolut FX TAVR system. The Evolut FX system is Medtronic’s latest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system. This system is designed to enhance ease-of-use and provide greater precision and control throughout the procedure.
The Evolut FX system maintains the industry-leading hemodynamic (blood flow) and durability benefits of the Evolut TAVR platform, while bringing product and procedure innovation for patients with symptomatic severe aortic stenosis.
The recent FDA go-ahead for the Evolut FX system is expected to bolster Medtronic’s Cardiovascular portfolio.
The Evolut FX is slated for a limited commercial release during the fall season with a full launch expected in early 2022.
Features in Detail
The Evolut FX system’s supra-annular valve design has demonstrated a superior hemodynamic performance over surgical aortic valve replacement (SAVR) across large-scale, randomized clinical trials.
The Evolut FX system is the fourth-generation Evolut technology. This system is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and valve leaflet location during implant.
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Additionally, the Evolut FX system incorporates a redesigned catheter tip for a smoother insertion profile, a more flexible delivery system that permits 360-degree freedom of motion, with a stable, predictable deployment. This system also includes four valve sizes for the largest indicated patient treatment range and the lowest delivery profile currently on the market, similar to its predecessor (EvolutPRO+).
More in the News
The Evolut FX system is part of the Evolut TAVR platform, which includes the Evolut R, Evolut PRO and Evolut PRO+. The Evolut TAVR platform is indicated for symptomatic severe aortic stenosis patients across all risk categories in the United States. Per management, the Evolut FX system refines the trusted Evolut platform with key product and procedural enhancements.
Industry Prospects
Envista Holdings, sporting a Zacks Rank #2 (Buy), has a long-term earnings growth rate of 27.4%.
BellRing Brands, which carries a Zacks Rank #2, has a long-term earnings growth rate of 29.1%.
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