The study compared the next-generation Evolut FX TAVR systems to earlier-generation Evolut systems. Data demonstrated significantly improved commissure alignment during TAVR procedures with Evolut FX.
A late-breaking presentation at PCR London Valves 2022 summarized the early limited market release of Evolut FX. The FDA approved the Evolut FX in August 2021. The study included data from 168 patients across six U.S. centers. It compared that data to outcomes for 378 Evolut PRO+ patients from a single center.
Medtronic said in a news release that commissure alignment represents a key aspect of TAVR procedures. It could provide easier future coronary access and improved coronary blood flow. It may also improve valve hemodynamic performance and facilitate redo-TAVR in the future.
Evolut FX features enhancements such as gold markers built into the frame. These facilitate the visualization of implant depth and valve commissure location during TAVR procedures. The system also employs a redesigned delivery system that enhances traceability and flexibility during valve deployment.
Study demonstrates procedural improvements of latest Medtronic TAVR system
“In this early experience the Evolut FX system provided several enhancements over the PRO+ system not only because of its easier trackability, but more importantly achieving a more symmetric deployment on release and improved commissural alignment with reduced coronary overlap,” said Dr. Gilbert Tang, surgical director of the structural heart program at Mount Sinai Health System, professor in the department of cardiovascular surgery at the Icahn School of Medicine at Mount Sinai and the study’s principal investigator. “These features resulting in better procedural predictability and consistency in TAVR may be critical in low risk patients and broaden the adoption of TAVR to a wider population. By looking closely at data across multiple centers, we’re able to demonstrate the procedural improvements of the FX system over its predecessors.”
The multicenter retrospective analysis demonstrated the achievement of commissural alignment in 95.8% of Evolut FX cases. It evaluated 89% of patients treated for symptomatic, severe native aortic stenosis and 11% for prosthetic valve degeneration. Thirty-day rates of death and stroke came in at 1.2% and 1.8%, respectively. Preliminary data also showed low rates (13.2%) of mild and no moderate or severe paravalvular leak (PVL) 30 days post-procedure.
“This is an exciting milestone in the treatment of aortic stenosis,” said Dr. Jeffrey Popma, VP and CMO for Medtronic’s Structural Heart & Aortic business. “These continued innovations will provide physicians with the key enhancements needed to improve precision and clinical experience. The preliminary real-world results from the Evolut FX system deliver on our goal to further enhance our TAVR platform to improve physician experience and optimize outcomes for patients.”