Medtronic (NYSE: MDT) today announced the launch of its Stedi extra support guidewire for use with its Evolut TAVR platform.
The medtech giant designed Stedi to enhance the performance of the transcatheter aortic valve replacement (TAVR) platform. It comes compatible with all commercially available TAVR systems for treating severe aortic stenosis. The guidewire has FDA clearance and is now available in the U.S.
Medtronic announced the launch of the new guidewire at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. It marks the latest development in the company’s TAVR offerings, following the recent announcement of a partnership with DASI to optimize outcomes for patients undergoing TAVR.
The company also received FDA approval for the expanded redo-TAVR indication of its Evolut system in August. This allows for the implantation of a new Evolut transcatheter aortic valve replacement (TAVR) system inside any previously implanted TAV that has failed. It came on the heels of CE mark for the Evolut Pro+, FX and FX+ systems for this indication.
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Engineered to complement Evolut, Stedi delivers enhanced support for stability, safety and predictability during valve deployment. It also eliminates the need to change implant technique. The guidewire combines a stiff proximal main body, a gradual stiffness transition and a distal curve.
Medtronic says testing demonstrated a reduction in venricular movement, improved stability and a more coaxial deployment with Stedi. When used with the cusp overlap technique, extra support guidewires also show a lower rate of permanent pacemaker implantation at 30 days.
“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, VP and GM 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.”
