Medtronic's Next-Generation Evolut FX+ TAVR System Receives CE Mark for Treatment of Symptomatic Severe Aortic Stenosis

Medtronic's Evolut FX+Transcatheter Aortic Valve Replacement (TAVR)The system has received CE Mark approval for the treatment of symptomatic severe aortic stenosis (AS). The deviceIn MarchObtainU.S. Food and Drug Administration (FDA)Approval.

Medtronic Designed the Evolut FX+ TAVR System with Improved Coronary Access in Mind. Its Coronary Access Window is Four Times Larger than Previous Evolut Valves.If patients require future coronary interventions after treatment, the maneuverability of catheters can be enhanced. With the increasing use of TAVR among younger patients, interventional cardiologists are now paying more attention to lifelong patient management than ever before. A significant number of these patients may need immediate treatment following myocardial infarction or other adverse health events. Improved access to the coronary arteries can save precious time for the care team.

"We are delighted to have achieved this significant milestone and to expand our severe aortic stenosis solution across Europe," said Vice President of Medtronic and General Manager of Structural Heart.Jorie Soskin） Through our continuous innovation commitment to the Evolut TAVI platform, we offer more advanced and minimally invasive treatment options to doctors and patients worldwide, with proven valve performance and durability.

"Medtronic Evolut FX+ System Represents a Significant Step in the Development of Cardiac Valve Disease Care," said the Director of the Department of Structural Heart Disease at Pasteur Hospital in Toulouse, France, and interventional cardiologistDidier Tchetche, M.D.Dr. added, "This advanced technology enables coronary access to multiple patient anatomies and provides clinicians with a modern tool to improve outcomes without compromising established valve performance. We are pleased to see this innovative solution gain approval in the European region and look forward to utilizing it for the benefit of patients."

The approval covers AS patients in all risk categories.