Medtronic has unveiled its newest-generation, transcatheter aortic valve replacement (TAVR) system, the Evolut FX TAVR system for symptomatic severe aortic stenosis.
The self-expanding Evolut FX upgrades the current Evolut platform with additional capabilities to improve the simplicity of use and predictable valve deployment for physicians.
Now available at all commercial TAVR sites in the US, the launch shows the firm’s commitment to the advancement of TAVR solutions.
According to the firm, the commercial launch of the Evolut FX system follows the US Food and Drug Administration (FDA) approval and a limited rollout earlier this year that received a positive response.
With significant design improvements, the Evolut FX system retains the hemodynamic (blood flow) and durability of the Evolut platform.
The improvements include a modified catheter tip for a smoother insertion profile, and gold indicators incorporated into the frame to provide implanters with a direct view of commissure alignment.
Evolut FX also has a more adaptable delivery system with an enhanced stability layer for a steadier and predictable deployment, said the firm.
Like its predecessor (Evolut PRO+), the system features four valve sizes for the broadest approved patient treatment spectrum and the lowest delivery profile currently available.
Medtronic Structural heart & aortic business chief medical officer and VP Jeffrey Popma said: “This represents a milestone for our structural heart business, as we look to set new expectations for TAVR delivery systems and optimize outcomes for patients.
“These innovations will equip physicians with improved implant predictability, ultimately improving the overall reliability of the procedure.”
Medtronic will present the new data at the upcoming 34th Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The company will release the results of four studies, including Late-Breaking Clinical Science, emphasising the most recent clinical knowledge on TAVR technology.
The studies provide fresh information from the Optimize PRO Study to the body of evidence supporting the Medtronic TAVR platforms.
