Medtronic announced that its Evolut FX transcatheter aortic valve replacement (TAVR) system has shown significantly improved commissure alignment during TAVR procedures in comparison to previous generation Evolut systems.
The medical device company said that a late breaker presentation at PCR London Valves 2022 outlined the early limited market release experience with the Evolut FX system in 168 people from six centres in the US. In addition to that, the data were compared to 378 patients on Evolut PRO+ from a single center.
Medtronic said that in the multicentre retrospective analysis, the Evolut FX system improved the commissural alignment in 95.8% of cases. It evaluated 89% of patients treated for symptomatic, severe native aortic stenosis, and 11% for prosthetic valve degeneration.
Additionally, the 30-day rates of death and stroke were found at 1.2% and 1.8%, respectively. The preliminary data also demonstrated low rates of mild and no moderate or severe paravalvular leak (PVL) 30 days post-procedure, the medical device firm added.
The system also reduced device recapture rates and more symmetric implant depths upon release. These results validate that the TAVR procedure with the FX platform is simpler and more predictable than previous generation systems, Medtronic claimed.
Medtronic vice president and structural heart and aortic business chief medical officer Jeffrey Popma said: “This is an exciting milestone in the treatment of aortic stenosis. 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.”
The Evolut FX system is the fourth generation of the TAVR platform of Medtronic. It secured approval from the US Food and Drug Administration (FDA) in 2021.
Evolut FX is said to have gold markings integrated within the frame for direct visualisation of depth and commissure alignment during the implant.
The medical device firm said that the latest generation of the device has a modified catheter tip for a smoother insertion profile. It also has a flexible delivery system that permits 360-degree freedom of motion.
