Medtronic plc has announced that its Stedi™ Extra Support Guidewire has received clearance from the U.S. Food and Drug Administration (FDA). The guidewire is designed to enhance the performance of the Evolut™ transcatheter aortic valve replacement (TAVR) platform and is compatible with all commercially available TAVR systems for patients with severe aortic stenosis. The Stedi™ Extra Stiff Guidewire is currently available in the United States. There is no indication that this grant or clearance involves multiple organizations.
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