FDA Approves Evolut TAVR System, Medtronic’s Treatment for Symptomatic Severe Aortic Stenosis

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Medtronic announced that the FDA has approved its Evolut FX+ transcatheter aortic valve replacement (TAVR) system to treat symptomatic severe aortic stenosis. The system offers enhanced features that facilitate easier coronary access without compromising valve performance, hemodynamics, or radial strength. Other features include a large coronary access window through a modified frame, which the company states improves space for catheter maneuverability. Medtronic expects the final product to be available on the market at some point this summer.¹

"We are committed to consistently developing and advancing minimally invasive solutions for physicians to treat their patients with aortic stenosis. This is reinforced by our continued innovation of the Evolut TAVR platform, which has delivered proven valve performance and durability to physicians and patients for years. The Evolut FX+ TAVR system was designed to facilitate coronary access across a diverse range of patient anatomies with no compromise to valve performance," said Jeffrey Popma, MD, VP, chief medical officer, Coronary & Renal Denervation business, Structural Heart & Aortic business, Medtronic, in a press release.

Back in 2021, the company’s OPTIMIZE PRO clinical study showed the first promising results for the Evolut TAVR system. As part of the study, 171 patients were treated. At 30 days, safety outcomes showed no deaths or strokes, an 8.8% pacemaker rate, and great blood flow performance.²

"The evolution of TAVR requires that we refine aspects of the procedure and post-procedure care pathways to improve patient outcomes," said trial co-principal investigator Kendra Grubb, MD, MHA, FACC, surgical director, Structural Heart and Valve Center at Emory Healthcare in Atlanta, in a press release. "Interim results from this study demonstrate improvements, like low pacemaker rates and next-day discharge, and are supportive of the hypothesis that the cusp overlap technique can improve patient care."

The study was conducted at a total of 46 sites throughout the United States and Canada, with an additional 15 in Europe. The primary endpoint focused on all-cause mortality and stroke rates after 30 days of the study. Additionally, secondary endpoints included discharge time, patients with more than moderate aortic regurgitation, and the rate of pacemaker implant for new-onset or worsening conduction disturbance after 30 days.²

"As a leader in transcatheter valves therapies, we are committed to helping implanting centers standardize and further refine their TAVR care pathways to improve patient outcomes," said Nina Goodheart, president, Structural Heart & Aortic business, Medtronic, in the press release. "In addition to helping us better understand the site-driven dynamics around conduction disturbance post-TAVR, the study also allows us to generate additional evidence around the Evolut PRO and PRO+ system's advanced sealing skirt and its impact on paravalvular leak."

References

1. Medtronic announces FDA approval of newest-generation Evolut TAVR system for treatment of symptomatic severe aortic stenosis. PR Newswire. March 27, 2024. Accessed March 28, 2024. https://www.prnewswire.com/news-releases/medtronic-announces-fda-approval-of-newest-generation-evolut-tavr-system-for-treatment-of-symptomatic-severe-aortic-stenosis-302100338.html

2. Procedure-Related Techniques and Care Pathways from the OPTIMIZE PRO Clinical Study Show Promising Early Outcomes for Patients Implanted with the Medtronic Evolut™ TAVR System. Medtronic. April 28, 2021. Accessed March 28, 2024.