Initially FDA approved in 2021, the company highlighted the new FX data in a recent late breaker presentation.

Katie Hobbins, Managing Editor

November 29, 2022

3 Min Read
medttronic (1).jpg
Image courtesy of Kristoffer Tripplaar / Alamy Stock Photo

Medtronic’s newest generation Evolut FX transcatheter aortic valve replacement system (TAVR) significantly improved commissure alignment during TAVR procedures compared to earlier generations, according to a new late breaker presentation at PCR London Valves 2022. The presentation summarized the early limited market release of the system in 168 patients from six United States centers and was compared to 378 Evolut PRO+ patients from a single center.

“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 Gilbert Tang, MD, MSc, MBA, 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 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 Evolut FX system is the fourth generation of Medtronic’s TAVR platform and received FDA approval in 2021. The newest generation comes with key enhancements that make the self-expanding system easier to use and is equipped with gold markers built into the frame to provide implanters with direct visualization of depth and commissure alignment during implant. Additionally, Evolut FX incorporates a redesigned catheter tip for smoother insertion, and more flexible delivery which allows for 360-degree use-of-motion with a stable and predictable deployment, according to the company.

The multicenter retrospective analysis included the 168 patients from six US centers, 89% of which were treated for symptomatic, severe native aortic stenosis and 11% for prosthetic valve degeneration. Aortic stenosis is a heart condition that occurs when the aortic valve narrows, preventing it from properly opening and closing, which causes the heart to work harder to pump blood to the rest of the body. The heart condition’s increased pressure within the heart makes it weaken and function poorly, causing potentially life-threatening symptoms. Aortic stenosis affects 3.4% of elderly people worldwide and as many as 50% of patients with severe symptoms may die after one year without appropriate treatment.

The analysis also showed that commissural alignment was achieved in 95.8% of Evolut FX cases, according to a company press release announcing the late breaker results. The data highlighted low 30-day rates of death and stroke at 1.2% and 1.8%, respectively. Preliminary data of the system also showed low rates of mild paravalvular leak (PVL) 30-days post-procedure (13.2%) and no moderate or severe PVL, along with hemodynamic performance similar to previous generation CoreValve and Evolut devices.

The findings demonstrated reduced device recapture rates and more symmetric implant depths upon release. The analysis results demonstrate that a TAVR procedure with the FX platform, according to Medtronic, is simpler and more predictable compared to earlier generations.

“This is an exciting milestone in the treatment of aortic stenosis,” said Jeffrey Popma, MD, vice president and chief medical officer for the structural heart & aortic business, which is part of the cardiovascular portfolio at Medtronic. “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.”

About the Author(s)

Katie Hobbins

Managing Editor, MD+DI

Katie Hobbins is managing editor for MD+DI and joined the team in July 2022. She boasts multiple previous editorial roles in print and multimedia medical journalism, including dermatology, medical aesthetics, and pediatric medicine. She graduated from Cleveland State University in 2018 with a bachelor's degree in journalism and promotional communications. She enjoys yoga, hand embroidery, and anything DIY. You can reach her at [email protected].

Sign up for the QMED & MD+DI Daily newsletter.

You May Also Like