Medtronic announces launch of Stedi™ Extra Support Guidewire to enhance Medtronic TAVR system performance

Medtronic plc, a global leader in healthcare technology, today announced the launch of the Stedi™ Extra Support guidewire, designed to enhance performance of the Evolut™ transcatheter aortic valve replacement (TAVR) platform - and compatible with all commercially available TAVR systems - for patients with severe aortic stenosis. The announcement was made during the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco, Calif.

Severe aortic stenosis occurs when the aortic valve leaflets become stiff and thickened and have difficulty opening and closing, making the heart work harder to pump blood to the rest of the body. Severe aortic stenosis often reduces a patient's quality of life and limits their daily activities. If left untreated, patients with symptomatic severe aortic stenosis can die from heart failure in as little as two years.¹The Evolut™ TAVR system provides a minimally invasive solution for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low).

Engineered to complement the Evolut platform, the Stedi guidewire delivers enhanced support for stability, safety and predictability during valve deployment² without requiring changes to implant technique. Developed specifically for TAVR procedures, Stedi combines a stiff proximal main body, gradual stiffness transition, and distal curve designed for stability, predictability, and safety.

"The Stedi Extra Support guidewire represents a meaningful advancement in TAVR," said Tanvir J. Bajwa, MD, interventional cardiologist at Advocate Health. "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."

Bench testing in a simulated anatomy has demonstrated that use of the Stedi guidewire, during deployment, when compared to less supportive wires with the Evolut platform, provides a reduction in ventricular movement, improved stability, and a more coaxial deployment.³ Additionally, when used with the cusp overlap technique, extra support guidewires have been shown to be associated with a lower rate of permanent pacemaker implantation at 30 days.⁴

"We continue to build a meaningful portfolio of procedural solutions which improve long-term outcomes for patients with aortic stenosis and advance the future of TAVR," said Jorie Soskin, vice president and general manager of the Structural Heart business within the Cardiovascular Portfolio at Medtronic. "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. Its thoughtful design supports procedural precision that can help drive improved patient-specific outcomes."

The Stedi™ Extra Stiff Guidewire has U.S. Food and Drug Administration clearance and is currently available in the United States.

For more information, visit https://medtronic.com/content/dam/medtronic-wide/public/united-states/products/cardiac-vascular/cardiovascular/guidewires/stedi-extra-support-guidewire-brochure.pdf

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission - to alleviate pain, restore health, and extend life - unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

¹Ross J Jr, Braunwald E. Aortic stenosis. Circulation. July 1968; 38(1 Suppl):61-67
² Medtronic data on file compared to competitor wires. Bench testing may not be indicative of clinical performance. Stiffness comparison, Deployment Stability, tests D01238423, Shape Retention tests D01312415. Competitor wires tested include Boston Scientific Safari wire, Boston Scientific Safari2 wire, Medtronic Confida wire, Symmedrix Innowi wire.
3 Medtronic data on file compared to competitor wires.†,‡ Bench testing may not be indicative of clinical performance. Stiffness comparison, Deployment Stability, tests D01238423
4 Yakubov S J, Optimize PRO Study: Global Standardized TAVI Technique and Care Pathway Results . Presented at London Valves; Nov 2024

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