Medtronic’s Evolut FX TAVR System Shown to Improve Commissure Alignment in Early Commercial Experience Data

November 29, 2022—Medtronic announced findings from early experience with the company’s Evolut FX system in 168 patients from six centers in the United States after the device’s limited market release. Additionally, these data were compared to 378 patients treated with the company’s Evolut Pro+ from a single center.

The Evolut FX is Medtronic’s newest-generation self-expanding transcatheter aortic valve replacement (TAVR) system. Medtronic announced FDA approval of Evolut FX in August 2021.

The company stated that Evolut FX is designed to significantly improve commissure alignment during TAVR procedures compared to earlier-generation Evolut systems. Commissure alignment is a key factor for easier future coronary access and improved coronary blood flow and valve hemodynamic performance, and it may facilitate redo TAVR in the future, noted the company.

The data were presented during the late-breaking trials session at the PCR London Valves 2022 course held November 27-29 in London, United Kingdom.

Gilbert Tang, MD, is Principal Investigator of the study, as well as Surgical Director of the Structural Heart Program at Mount Sinai Health System and Professor in the Department of Cardiovascular Surgery at the Icahn School of Medicine at Mount Sinai in New York, New York.

“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,” commented Dr. Tang in Medtronic’s press release. “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.”

Dr. Tang added, “By looking closely at data across multiple centers, we’re able to demonstrate the procedural improvements of the FX system over its predecessors.”

As summarized by Medtronic, commissural alignment was achieved in 95.8% of Evolut FX cases in the multicenter retrospective analysis of 168 patients at six centers (89% treated for symptomatic severe native aortic stenosis and 11% for prosthetic valve degeneration).

The 30-day rates of death and stroke were 1.2% and 1.8%, respectively. Preliminary data of the Evolut FX system also showed a low rate (13.2%) of mild paravalvular leak (PVL) and no moderate or severe PVL at 30 days after the procedure, with excellent hemodynamic performance similar to earlier-generation Medtronic CoreValve and Evolut devices, noted the press release.

In addition to improved commissure alignment with the Evolut FX system, Medtronic stated that the findings in this early experience demonstrated reduced device recapture rates and more symmetric implant depths on release, making TAVR with the FX platform simpler and more predictable than earlier-generation systems.