đź“Š Evidence-Based Reference
new hydrophilic coating for wire guides
Arrow Intl.
Summary: The new hydrophilic coating for wire guides by Arrow Intl. is designed to enhance the performance of wire guides in medical procedures. It is FDA 510k cleared with evidence from 11 studies highlighting its clinical applications and safety profile.
FDA Clearance Information
Pathway
510K
Number
K924385 ↗
Decision Date
August 15, 1993
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
The hydrophilic coating for wire guides by Arrow Intl. received FDA clearance through the 510k pathway on August 15, 1993. It is classified as a Class 2 device under product code DQX.
What It Is
This device is a hydrophilic coating applied to wire guides, intended to improve their maneuverability and reduce friction during medical procedures. It is used in various interventional procedures to facilitate the navigation of wire guides through the vasculature.
Clinical Applications
Commonly used in procedures requiring the insertion and manipulation of wire guides, such as angiography and embolization. The hydrophilic coating aids in reducing friction, thus enhancing the ease of use in complex vascular pathways.
Evidence Summary
The literature includes 11 studies, encompassing various study designs such as RCTs and case series, conducted between 2018 and 2024. These studies explore the safety and effectiveness of hydrophilic coatings in clinical settings.
Reported Outcomes
Published studies report that hydrophilic coatings on devices like stents and wire guides can reduce platelet adhesion and thrombogenicity. The evidence suggests improved procedural outcomes due to enhanced device maneuverability and reduced complications related to device insertion.
Safety Profile
Reported complications include device-related infections and dissatisfaction, although these are relatively rare. The studies indicate a high implant survival rate, with minimal adverse events directly attributed to the hydrophilic coating.
Evidence Limitations
Current evidence is limited by the variability in study designs and the relatively small sample sizes in some studies. Further research is needed to establish long-term outcomes 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 the hydrophilic coating for wire guides?
The device is indicated for use in procedures requiring wire guide insertion, such as angiography and embolization, to improve maneuverability and reduce friction.
What outcomes have been reported in clinical studies?
Studies have reported improved procedural outcomes due to reduced friction and enhanced device maneuverability, with a high implant survival rate.
What complications have been reported?
Reported complications include device-related infections and dissatisfaction, though these events are rare.
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.