📊 Evidence-Based Reference

naviguide hydrophilic coated guidewire

Meadox Medicals, Div. Boston Scientific

Summary: The Naviguide Hydrophilic Coated Guidewire is used primarily in endovascular procedures for navigating through complex vasculature. Key evidence highlights its role in reducing friction during procedures, though complications like coating fragmentation have been noted.

FDA Clearance Information

Pathway 510K
Decision Date December 21, 1992
Product Code DQX
Device Class Class 2
Evidence 419 studies

The Naviguide Hydrophilic Coated Guidewire was cleared by the FDA via the 510(k) pathway on December 21, 1992. It is manufactured by Meadox Medicals, a division of Boston Scientific, and is classified as a Class 2 medical device.

What It Is

The Naviguide Hydrophilic Coated Guidewire is a medical device designed to assist in the navigation of blood vessels during endovascular procedures. Its hydrophilic coating reduces friction, facilitating smoother passage through tortuous or narrow vessels.

Clinical Applications

This guidewire is commonly used in procedures such as coronary interventions, neuroendovascular therapy, and other vascular access procedures where precise navigation through complex vessel anatomy is required.

Evidence Summary

The available literature includes a mix of retrospective and prospective studies, case series, and other study types, with a total of 10 studies published between 2010 and 2023. These studies explore various aspects of the guidewire's performance and safety.

Reported Outcomes

Published studies report that the Naviguide Hydrophilic Coated Guidewire is effective in facilitating endovascular procedures by reducing friction and aiding in the navigation of complex vasculature. However, some studies have noted issues with coating fragmentation, which could potentially lead to embolic events.

Safety Profile

Reported complications include fragmentation of the hydrophilic coating, which may lead to embolic events during neuroendovascular therapy. Other potential adverse events include entrapment and detachment of the guidewire tip, though these are infrequent.

Evidence Limitations

The evidence is limited by the small sample sizes and the retrospective nature of many studies. Further research is needed to fully understand the long-term safety implications of coating fragmentation and to explore potential mitigation strategies.

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 Naviguide Hydrophilic Coated Guidewire?

The guidewire is indicated for use in endovascular procedures requiring navigation through complex vasculature, such as coronary and neuroendovascular interventions.

What outcomes have been reported in clinical studies?

Studies report effective navigation and reduced friction during procedures, though some note issues with coating fragmentation.

What complications have been reported?

Safety data indicate potential complications such as coating fragmentation leading to embolic events and rare cases of guidewire tip 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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