www.fdanews.com/articles/204127-medtronics-evolut-aortic-stenosis-treatment-device-gets-fda-approval
Medtronic’s Evolut Aortic Stenosis Treatment Device Gets FDA Approval
August 26, 2021
Medtronic has received FDA approval for its Evolut FX TAVR self-expanding transcatheter aortic valve replacement system.
The Evolut FX is designed to enhance ease-of-use and provide greater precision in surgical procedures for patients with symptomatic severe aortic stenosis, Medtronic says.
The device has gold markers built into the frame to provide implanters with direct visualization of depth and valve flap location during surgery.