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Transcatheter systems

Stedi™ extra support guidewire

<p>The Stedi™ extra support guidewire is designed for transcatheter aortic valve replacement (TAVR).</p>

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Features

Balancing support with flexibility where it matters most2

The Stedi™ guidewire delivers enhanced support for stability, safety, and predictability during deployment.3

Pre-shaped distal curve

  • Maintained a stable position during delivery system tracking and valve deployment4
  • Improved shape retention to support reliable procedural performance4
This is an image of the Stedi™ extra support guidewire.

Enhanced main body support

Maintained through the full length of the aortic arch and annulus5

Continuous tapered core

Gradual stiffness transition to minimize the risk of ventricular perforation6

This is an illustration of the Stedi™ extra support guidewire internal core.

Extended introducer length

To fully straighten the pre-shaped tip for efficient insertion into diagnostic guide catheter7

This is an image of the Stedi™ extra support guidewire introducer.
This is an image of the Stedi™ extra support guidewire being used to deploy a valve in a transcatheter aortic valve (TAV) procedure.

Facilitating a more stable valve deployment8


Compared to less supportive wires‡ in bench testing, Stedi™ guidewire demonstrated:
 

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Improved initial stability‡,8

p < 0.001

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Reduced ventricular movement‡,8

p < 0.001

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Reduced valve canting‡,8

p < 0.001

When used with cusp overlap technique, extra support guidewires have been shown to be associated with a lower rate of permanent pacemaker implantation at 30 days.§,9,10

The Stedi™ extra-support guidewire is intended to introduce and position catheters during interventional procedures within the chambers of the heart, including transcatheter aortic valve replacement. Risks may include, but are not limited to, allergic reaction, embolism, hemolysis, damage to the vessels, and bleeding.

Ordering information

Item number Description Length (cm) Distal curve height (mm) Labeled OD (in / mm)
STEDI-3 Guidewire 275 3 0.035 / 0.89
STEDI-4 Guidewire 275 4 0.035 / 0.89



Resources

Related links

Get support.

Reach out to Lifeline Cardiovascular Tech Support with questions.

Phone: 877-526-7890

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Education and resources

Find more detailed TAVR information, educational resources, and tools.

Visit Medtronic Academy (open in new window)

Clinical evidence

The Medtronic CoreValve™/Evolut™ platform is supported by a robust body of clinical evidence. Explore the CoreValve™/Evolut™ clinical success.

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Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

TM* Third-party brands are trademarks of their respective owners.

† Competitor wires tested include Boston Scientific Safari™* wire, Boston Scientific Safari2™* wire, Medtronic Confida™ wire, Symmedrix Innowi™* wire.

‡ Competitor wires tested include Boston Scientific Safari™* wire, Boston Scientific Safari2™* wire, Medtronic Confida™ wire.

§ Optimize PRO study demonstrated that use of a stiff guidewire (Lunderquist®*) along with cusp overlap technique is associated with a low PPI rate of 9.8% in the main cohort at 30 days.

  1. Medtronic data on file compared to competitor guidewires.† Bench testing may not be indicative of clinical performance. Deployment stability, Design Validation tests: D01238423, D01286799.

  1. Medtronic data on file compared to competitor wires.† Bench testing may not be indicative of clinical performance. Stiffness comparison test: D01238423.
  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.
  3. Medtronic data on file compared to competitor guidewires.‡ Bench testing may not be indicative of clinical performance. Shape retention tests: D01312415, M049539CDOC1.
  4. Medtronic data on file compared to competitor wires.† Bench testing may not be indicative of clinical performance. Outer Curvature test: D01238423.
  5. Medtronic data on file. Bench testing model may not be indicative of clinical performance. Design file: M049539CDOC1.
  6. Medtronic data on file. Bench testing model may not be indicative of clinical performance. HFE Usability Design Validation tests: D01286799, M049539CDOC1.
  7. Medtronic data on file compared to competitor wires.‡ Bench testing may not be indicative of clinical performance. Deployment Stability test: D01238423.
  8. Yakubov S. Optimize PRO study: Global standardized TAVI technique and care pathways results. Presented at: PCR London Valves; November 24–26, 2024; London, England.
  9. Medtronic bench testing model on file demonstrates Stedi™ wire possesses a similar stiffness profile to Lunderquist wire. D01238423.