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naviguide hydrophilic guide wire
Meadox Medicals, Div. Boston Scientific
Summary: The Naviguide Hydrophilic Guide Wire is a medical device used primarily in embolization procedures. Key evidence highlights its role in reducing air embolism during catheter exchanges.
FDA Clearance Information
Pathway
510K
Number
K943358 ↗
Decision Date
June 2, 1995
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
The Naviguide Hydrophilic Guide Wire was cleared by the FDA via the 510(k) pathway on June 2, 1995. It is manufactured by Meadox Medicals, a division of Boston Scientific, and is classified as a Class 2 device.
What It Is
The Naviguide Hydrophilic Guide Wire is designed to assist in the placement of catheters during embolization procedures. Its hydrophilic coating facilitates smooth navigation through vascular pathways, minimizing trauma to vessel walls.
Clinical Applications
Commonly used in procedures requiring precise catheter placement, such as central venous catheter exchanges and endoscopic retrograde cholangiopancreatography (ERCP). It is particularly useful in scenarios where reduced friction is beneficial.
Evidence Summary
The available literature includes 10 studies, ranging from randomized controlled trials to case reports, published between 2020 and 2024. These studies explore various clinical applications and safety profiles of the guide wire.
Reported Outcomes
Published studies report that the Naviguide Hydrophilic Guide Wire effectively reduces air embolism during catheter exchanges. It is also noted for its utility in challenging endoscopic procedures, such as ERCP, where precision is critical.
Safety Profile
Reported complications include rare instances of guide wire fracture and hydrophilic coating detachment. These events underscore the importance of careful handling and monitoring during procedures.
Evidence Limitations
Current evidence is limited by small sample sizes and a lack of long-term outcome data. Further research is needed to establish standardized protocols and to explore the full range of clinical applications.
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
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 Guide Wire?
The guide wire is indicated for use in embolization procedures and catheter placements, particularly where reduced friction is advantageous.
What outcomes have been reported in clinical studies?
Studies have shown its effectiveness in reducing air embolism during catheter exchanges and its utility in precise endoscopic procedures.
What complications have been reported?
Safety data indicate rare occurrences of guide wire fracture and hydrophilic coating detachment.
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.