📊 Evidence-Based Reference

Wire Guide Catheter

Lake Region Mfg.

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Summary: The wire guide catheter by Lake Region Mfg. is a device cleared by the FDA for use in venous-stent procedures. Key evidence highlights its application in complex catheter exchanges and embolization techniques.

FDA Clearance Information

Pathway ? 510(k)
Number ? K850829 ↗
Decision Date ? June 26, 1985
Product Code ? DQY Catheter, Percutaneous
Device Class ? Class 2
Evidence ? 0 studies

The wire guide catheter was cleared through the FDA 510(k) pathway on June 26, 1985. It is manufactured by Lake Region Mfg. and classified as a Class 2 device under product code DQY.

What It Is

The wire guide catheter is a medical device used to facilitate the placement of stents in venous procedures. It serves as a conduit for other instruments, providing support and direction during catheterization.

FDA-Cleared Indications

  • Percutaneous catheterization of blood vessels.
  • Use as a catheter conduit to support the placement, exchange, or guidance of other vascular instruments.
  • Use during vascular procedures requiring controlled catheter positioning under imaging guidance.

Clinical Applications

  • Providing support during venous catheter exchanges.
  • Facilitating catheter placement for venous stenting procedures.
  • Serving as a conduit for guidewires or other compatible instruments during percutaneous vascular procedures.
  • Supporting access and instrument positioning in iliac or central venous interventions.

Reported off-label uses

  • Use as an access or support catheter during selected embolization procedures when clinically appropriate and compatible with the device specifications.
  • Use in complex catheter navigation during neurointerventional procedures, when the device is suitable for the intended anatomy and technique.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Evidence Summary

The literature includes 15 studies, comprising RCTs, retrospective analyses, and case series, published between 2024 and 2025. These studies explore various techniques and applications of the wire guide catheter.

Reported Outcomes

Published studies report successful use of the wire guide catheter in complex catheter exchanges and embolization procedures. Techniques such as balloon shaft-assisted exchanges and magnetism-enhanced guide wires have shown promising results in enhancing procedural success.

Safety Profile

Reported complications include potential air embolism during catheter exchanges, which can be mitigated by specific techniques such as the catheter clamp over hydrophilic guide wire method. No major adverse events were highlighted in the reviewed studies.

Evidence Limitations

The evidence is limited by the small number of studies and the lack of large-scale RCTs. Further research is needed to establish long-term outcomes and safety profiles across diverse patient populations.

Practical Considerations

  • The catheter must be selected for the intended vessel, access route, guidewire size, and other device compatibility requirements.
  • Available dimensions, lumen configuration, radiopacity, and pressure limits depend on the specific model and its labeling.
  • Placement and manipulation should be performed with appropriate imaging guidance by trained clinicians.
  • MRI safety is model-specific; the device should not be assumed to be MR Safe or MR Conditional without current manufacturer labeling.
  • Potential complications include bleeding, infection, vessel injury, thrombosis, embolization, catheter fracture, and malposition.

Procedures that use this device

Frequently Asked Questions

What are the clinical indications for wire guide catheter?

The wire guide catheter is indicated for use in venous-stent procedures, including complex catheter exchanges and embolization of intracranial aneurysms.

What outcomes have been reported in clinical studies?

Studies report successful catheter exchanges and embolization procedures, with techniques enhancing procedural support and reducing complications.

What complications have been reported?

Reported complications include potential air embolism during catheter exchanges, which can be reduced with specific procedural techniques.

Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference. It does not constitute medical advice, product endorsement, or a recommendation for clinical use. Always consult manufacturer documentation and clinical judgment for patient care decisions.

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