Medtronic Launches Stedi™ Extra Support Guidewire to Enhance TAVI Procedure Precision and Stability

Medtronic Announces Launch ofStediReinforced Support Guidewire,StediAimed at enhancing the stability during the valve deployment phase in transcatheter aortic valve implantation (TAVI), specifically tailored for Medtronic's Evolut series of TAVI products. This product has now received FDA approval and is on the market.

Expert Evaluation

"Stedi Enhanced Support Guidewire Represents an Important Advancement in TAVI Technology, Significantly Enhancing Stability and Predictability During Valve Deployment, Especially When Used with Simplified Leaflet Overlap Techniques, Further Strengthening Procedural Consistency When Paired with the Evolut Platform. This Innovation Aids in Achieving More Predictable Treatment Outcomes and the Precision We Always Strive for When Treating Patients with Severe Aortic Stenosis."

---Tanvir J Bajwa  Advocate Health

Executive Evaluation

"We continue to build a portfolio of surgical solutions with clinical value, aiming to improve the long-term outcomes for patients with aortic stenosis and drive the future development of TAVI technology. Stedi guidewire is an important addition to our expanding TAVI product portfolio — its thoughtful design not only meets the current and future clinical needs of physicians, but also enhances the stability and predictability of procedures while seamlessly integrating into the existing Evolut workflow. This user-centric design helps improve procedural precision, thereby delivering more personalized treatment outcomes for patients."

---Jorie Soskin  Vice President and General Manager of Structural Heart Division, Cardiovascular Portfolio at Medtronic

According to MedtronicStediCannot match Medtronic itselfEvolut series products, can also be compatibleAll commercially available TAVI products for the treatment of severe aortic stenosis.

Medtronic has recently made moves in the TAVI field, besides continuing to upgradeOutside of the Evolut system products, it is expanding.Evolut System Product Indications (CE and FDA approvals in May and August this year, respectively)Evolut series products are used for secondary TAVR,It allows doctors to implant a brand-new Evolut transcatheter aortic valve (TAVR) within any failed transcatheter aortic valve (TAVR).

In addition to continuously optimizing and expanding the indications for TAVI implants, Medtronic is also actively innovating in the field of TAVI surgical accessories.For example, recently withDASI established a collaboration to introduce AI technology into TAVI procedures, thereby improving outcomes for TAVI patients. Additionally, the launch of a guidewire specifically designed for TAVI surgeries has further strengthened Medtronic's competitive edge in the TAVI field. This positions them to take more initiative in future competition with Edwards, enabling them to capture a larger market share even without a reflux valve.

Stedi

StediIt is Medtronic.Previous Generation GuidewireConfida Brecker Guidewire Upgrade Version, ItsFeaturing a proximal rigid body design, with a progressive stiffness transition segment and a distal pre-shaped bend, specifically engineered to enhance stability, predictability, and safety.

StediThe guidewire has a diameter of 0.035 inches (approximately 0.89 millimeters) and a total length of 275 centimeters, consisting of two core components: the core wire and the coil. All components areMade of stainless steel material. The core wire is made of stainless steel wire, and the distal end is finely ground and embedded inside the coil to provide flexibility. The coil and the ground core wire are doubly fixed through a proximal bonding point and a distal welding point.

StediThe distal end is pre-shaped with a 540° arc, available in two specifications (3 cm and 4 cm arc length). To enhance lubricity, the entire length of the guidewire is coated with polytetrafluoroethylene (PTFE).

Medtronic inDiscovered in the bench test simulating anatomical structures,Compared with less supportive guidewires, using the Evolut platformStediDuring valve deployment, it can reduce ventricular movement, enhance stability, and achieve more coaxial implantation.

Stedi Advantages

• Stability Design

Enhanced main body support force, with a coverage range spanning the entire aortic arch and valve annulus.

Reduce the intraventricular movement of the TAVI valve to enhance deployment stability.

• Safety Design

The pre-shaped tip is designed to achieve atraumatic contact with the anatomy.

Continuous tapered core wires combined with a gradual stiffness transition help reduce the risk of ventricular perforation.

• Characteristics of the Introducer Sheath

Extended introducer sheath length designed to enhance the efficiency of guidewire insertion into diagnostic guiding catheters.

The pre-shaped distal curve maintains a stable position during delivery system tracking and valve deployment.

Enhanced shape retention capability supports reliable surgical performance.