Medtronic launches FDA-cleared guidewire compatible with multiple TAVR systems
Medtronic has launched a new guidewire designed to improve the overall performance of transcatheter aortic valve replacement (TAVR) systems—including those made by other manufacturers.
The Stedi Extra Support guidewire includes updated features that have been implemented to improved stability, safety and predictability. It does not require any changes to the valve implant technique.
The new device, which has been cleared by the U.S. Food and Drug Administration, works with Medtronic’s family of self-expanding Evolut TAVR devices. It is also compatible with all other commercially available TAVR systems.
According to Medtronic, early data suggest the new device is associated with a reduction in ventricular movement, better stability and a more coaxial deployment when compared to other guidewires. Pairing it with the cusp overlap technique, the company noted, may help reduce a patient’s risk of requiring a permanent pacemaker following TAVR.
“The Stedi guidewire is a complementary addition to our growing TAVR portfolio—purposefully designed to meet the evolving needs of physicians today and for the future, delivering enhanced stability and predictability while seamlessly integrating into existing Evolut workflows,” Jorie Soskin, vice president and general manager of Medtronic’s structural heart business, said in a statement. “Its thoughtful design supports procedural precision that can help drive improved patient-specific outcomes.”
“The Stedi Extra Support guidewire represents a meaningful advancement in TAVR,” added Tanvir K. Bajwa, MD, an interventional cardiologist at Advocate Health familiar with the device. “It enhances stability and predictability during valve deployment, especially when paired with techniques like simplified cusp overlap, and reinforces procedural consistency with the Evolut platform. This innovation supports more predictable outcomes and the precision we strive for in treating patients with severe aortic stenosis.”
Medtronic officially launched the new guidewire at TCT 2025 in San Francisco. Click here for more information about the four-day conference.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.