New self-expanding TAVR system gains FDA approval

Michael Walter | | Cardiovascular Business | TAVR
approved approval

The newest addition to Medtronic’s Evolut transcatheter aortic valve replacement (TAVR) platform, the Evolut FX system, has been approved by the FDA.

The system is approved for the treatment of symptomatic severe aortic stenosis in patients from all risk categories. It was designed with gold markers that boost implanter efficiency, a new-look catheter tip and “a more flexible delivery system that allows for 360-degree freedom of motion.”

“The self-expanding, supra-annular Evolut platform has evolved considerably over time and has brought heart teams innovative features like recapturability, an expanded size matrix and advanced valve sealing to help minimize paravalvular leak,” Jeffrey Popma, MD, vice president and chief medical officer of Medtronic’s Coronary & Renal Denervation and Structure Heart & Aortic business lines, said in a prepared statement. “Today, the Evolut FX system further refines a trusted platform with key product and procedural enhancements that make the self-expanding system easier to use with enhanced visualization capabilities for orientation and depth.”

Medtronic is planning a limited release of the Evolut FX TAVR system in the months ahead, with “a full launch” scheduled for early 2022.

Michael Walter
Michael Walter, Managing Editor

Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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