📊 Evidence-Based Reference

Quickwire - Hydrophilic Coated Guidewire

Meadox Surgimed

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Summary: The quickwire is a hydrophilic coated guidewire used primarily in embolization procedures. Key evidence highlights its role in facilitating complex interventions with noted safety concerns regarding coating fragmentation.

FDA Clearance Information

Pathway ? 510(k)
Number ? K904582 ↗
Decision Date ? February 25, 1991
Product Code ? DQX Wire, Guide, Catheter
Device Class ? Class 2
Evidence ? 419 studies

The quickwire by Meadox Surgimed was cleared through the FDA 510(k) pathway on February 25, 1991. It is classified as a Class 2 device under product code DQX.

What It Is

The quickwire is a hydrophilic coated guidewire designed to assist in the navigation of vascular pathways during embolization procedures. Its coating reduces friction, aiding in the smooth passage through tortuous vessels.

FDA-Cleared Indications

  • Used to facilitate the placement and positioning of catheters within blood vessels during diagnostic or therapeutic intravascular procedures.
  • Intended for use with compatible intravascular catheters under fluoroscopic guidance.

Clinical Applications

  • Guidewire assistance during vascular catheterization.
  • Navigation through tortuous or difficult vascular anatomy.
  • Catheter positioning during embolization procedures when consistent with the device labeling.
  • Guidewire support for other labeled diagnostic or therapeutic endovascular procedures.

Reported off-label uses

  • Use in selected complex neurovascular interventions beyond the specific indications in the original labeling.
  • Use as an exchange or support wire in procedures not specifically identified in the original device labeling.

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 10 studies ranging from 2010 to 2023, encompassing various study designs such as RCTs, case series, and retrospective analyses. These studies explore both the efficacy and safety of the device.

Reported Outcomes

Published studies report that the quickwire facilitates successful navigation in complex vascular procedures, with advantages noted in cases of extreme vessel tortuosity. However, outcomes vary depending on the clinical scenario and patient-specific factors.

Safety Profile

Reported complications include fragmentation of the hydrophilic coating, which can lead to embolic events. Other studies highlight rare occurrences of guidewire entrapment and potential cardiovascular complications.

Evidence Limitations

The evidence is limited by small sample sizes and a lack of large-scale RCTs. Further research is needed to better understand long-term outcomes and the mechanisms behind coating fragmentation.

Practical Considerations

  • Use only with catheters and accessories compatible with the wire's diameter, length, tip configuration, and intended vascular application.
  • Hydrophilic coatings should be activated and maintained according to the manufacturer's instructions; inadequate wetting can increase friction.
  • Avoid excessive force, sharp bending, repeated manipulation, or withdrawal through a tight catheter, which may damage the wire or coating.
  • Inspect the wire before use and discontinue it if the coating, tip, or wire structure appears damaged; coating fragmentation can cause embolic complications.
  • MRI safety status, available sizes, and maximum recommended indwelling time should be confirmed in the current manufacturer labeling. This guidewire is generally intended for temporary procedural use rather than implantation.

Linked Studies (20)

PubMed • 2025

Onyx Liquid Embolic Agent: Basic Knowledge for Its Use in Interventional Neuroradiology.

Journal of neuroendovascular therapy

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Performance evaluation of quantitative hemoglobin A2 and fetal hemoglobin testing using commercially lyophilized vs. in-house whole blood controls in Chinese clinical laboratories: a 12-year analysis of National External Quality Assessment Data.

Clinical chemistry and laboratory medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical progress note: Haemophilus influenzae type b.

Journal of hospital medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Pilot study of social media promotion of home-based self-testing for syphilis.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Clinical development and performance of the First to Know Syphilis Self-Test for over-the-counter usage: a de novo rapid test for treponemal antibody.

Journal of clinical microbiology

View Source →
PubMed • 2025

Implementation of an Opt-Out and Rapid Point-of-Care Syphilis Testing Program for Pregnant Patients Presenting to the Emergency Department.

Sexually transmitted diseases

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Evaluation of Rapid Syphilis Testing Using the Syphilis Health Check in Florida, 2015-2016.

Florida public health review

View Source →
PubMed • 2025

Multiplex droplet digital PCR for the detection and quantitation of Streptococcus pneumoniae, Mycoplasma pneumoniae, and Haemophilus influenzae.

Frontiers in cellular and infection microbiology

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Palm Multidiagnostic of Mycoplasma pneumoniae, Chlamydia pneumoniae, Haemophilus influenzae, and Streptococcus pneumoniae Using One-Tube CRISPR/Cas12a.

Transboundary and emerging diseases

View Source →
PubMed • 2025

Tp40: a new potential prognostic and diagnostic marker for syphilis.

Microbiology spectrum

View Source →
PubMed • 2025

Serotonin sets up neutrophil extracellular traps to promote neuroendocrine prostate cancer metastasis in the liver.

The Journal of clinical investigation

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Application value of Philips Ingenuity TF PET/CT scanner imaging agent FAP in evaluating renal fibrosis.

Hellenic journal of nuclear medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Message from Dr. Philippe T. Georgel, Guest Editor for the Marshall University Collection, Brad D. Smith, President of Marshall University, and Dr. Anivandan Mukherjee, Provost of Marshall University.

Biochemistry and cell biology = Biochimie et biologie cellulaire

View Source →
PubMed • 2025

Editorial - Philippe Ascher (1936-2022).

Neuroscience

View Source →
PubMed • 2025

Improved patient comfort and procedural efficiency using chlorhexidine-coated hydrophilic urethral catheters: a randomized controlled trial.

Journal of Yeungnam medical science

RCT View Source →
PubMed • 2025

pTx-Pulseq in hybrid sequences: Accessible and advanced hybrid open-source MRI sequences on Philips scanners.

Magnetic resonance in medicine

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Comparative connectomics of Drosophila descending and ascending neurons.

Nature

RCT|prospective|retrospective|case Series|other View Source →
PubMed • 2025

Hydrophilic-coated sheaths for reducing radial artery spasm during transradial procedures: A systematic review and meta-analysis.

Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences

View Source →
PubMed • 2025

History of antineutrophil cytoplasmic autoantibodies : Milestones in rheumatology.

Zeitschrift fur Rheumatologie

View Source →
PubMed • 2025

A Hydrophilic Polyurethane Foam Containing Nigella sativa Oil as a Wound Dressing.

BioMed research international

RCT|prospective|retrospective|case Series|other View Source →

Frequently Asked Questions

What are the clinical indications for quickwire?

The quickwire is indicated for use in embolization procedures and other interventions requiring navigation through complex vascular pathways.

What outcomes have been reported in clinical studies?

Studies report successful navigation in complex procedures, with specific advantages in tortuous vessel scenarios.

What complications have been reported?

Safety data indicate risks of coating fragmentation leading to embolic events and rare occurrences of guidewire entrapment.

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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