The gold markers, visible on X-ray imaging, have been perhaps the most publicized of the Evolut FX valve’s new features since the device first launched. In one recent study published in Circulation: Cardiovascular Interventions, for instance, researchers wrote that the radiopaque markers were able to help TAVR operators confirm commissural alignment during TAVR.[1]

“This exciting milestone helps us continually enhance a trusted platform to better respond to clinicians' needs making TAVR procedures easier to visualize and more predictable for heart teams,” Jeffrey Popma, MD, vice president and chief medical officer of Medtronic’s structural heart and aortic business, said in a prepared statement. “Receiving CE Mark for the Evolut FX system highlights our commitment to providing minimally invasive treatment options globally for patients experiencing severe aortic stenosis.”

“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,” added Danny Dvir, MD, 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.”

Now that Medtronic has gained this key approval, the company expects the Evolut FX valve to be commercially available throughout Europe in “the coming weeks.”