Medtronic has announced the expanded US market release of its newest-generation, self-expanding transcatheter aortic valve implant (TAVI) system, Evolut FX.
Evolut FX adds new features to the existing Evolut platform to enhance ease-of-use and predictable valve deployment for physicians, Medtronic said in a press release.
The full commercial release of the Evolut FX system follows US Food and Drug Administration (FDA) approval and a limited roll out earlier this year. With this latest expansion, the Evolut FX system will be available to all commercial TAVI sites across the USA.
Updates in the new platform include gold markers built into the frame to provide implanters with direct visualisation of commissure alignment; a redesigned catheter tip for a smoother insertion profile; and a more flexible delivery system that features an optimised stability layer for a more stable deployment.
“This represents a milestone for our structural heart business, as we look to set new expectations for TAVI delivery systems and optimise outcomes for patients. These innovations will equip physicians with improved implant predictability, ultimately improving the overall reliability of the procedure,” said Jeffrey Popma, vice president and chief medical officer for the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic.