Medtronic
(NYSE: MDT)
this week announced it received CE mark approval for the Evolut FX transcatheter aortic valve implantation system.
The Evolut FX is the latest generation TAVI of the company’s CoreValve/Evolut TAVI platform. Medtronic designed it to enhance ease-of-use and provide greater precision and control throughout the procedure for clinicians treating patients with severe aortic stenosis.
Evolut FX uses the same supra-annular, self-expanding valve design as the CoreValve/Evolut platform. It has gold markers built into he frame to provide implanters with direct visualization of depth and valve leaflet orientation during implant. Evolut FX uses a redesigned catheter for a smoother insertion profile and more flexible delivery system for a stable, predictable deployment, according to Medtronic.
“With the latest Evolut FX system, we are elevating the precision, control and predictability of transcatheter aortic valve replacement procedures for patients with severe aortic stenosis,” said Danny Dvir, interventional cardiologist and director of Interventional Cardiology and Cath Labs at Shaare Zedek Hospital Canter in Jerusalem, Israel. “The system provides physicians with an innovative solution to meet the needs of a patient population desiring to get back to their active lifestyles sooner.”
Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder. If left untreated, patients with symptomatic severe aortic stenosis could die from heart failure.
“This exciting milestone helps us continually enhance a trusted platform to better respond to clinicians’ needs making TAVI procedures easier to visualize and more predictable for heart teams,” Jeffrey Popma, vice president and chief medical officer for the Coronary & Renal Denervation business and the Structural Heart & Aortic business, which are part of the Cardiovascular Portfolio at Medtronic, said in a news release. “Receiving CE Mark for the Evolut FX system highlights our commitment to providing minimally invasive treatment options globally for patients experiencing severe aortic stenosis.”
Evolut FX is indicated for use in adult patients with severe aortic stenosis across all risk categories in the European Union. It is also indicated for symptomatic severe aortic stenosis patients across all risk categories in the U.S.
Medtronic plans to make the TAVI device commercially available across Europe in the coming weeks.