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hydrophilic coating guide wire
Suzhou Hengrui Disheng Medical
Summary: The hydrophilic coating guide wire by Suzhou Hengrui Disheng Medical is primarily used in endovascular procedures. Key evidence highlights its role in reducing central vein punctures and pneumothorax incidence.
FDA Clearance Information
Pathway 510K
Number K193653 ↗
Decision Date August 26, 2020
Product Code DQX
Device Class Class 2
Evidence 419 studies
The hydrophilic coating guide wire received FDA clearance through the 510(k) pathway on August 26, 2020. It is manufactured by Suzhou Hengrui Disheng Medical and classified as a Class 2 device.
What It Is
The hydrophilic coating guide wire is designed to facilitate navigation through vascular systems during endovascular procedures. Its hydrophilic coating reduces friction, aiding in smoother insertion and maneuverability.
Clinical Applications
Commonly used in procedures such as embolization and endovascular therapy, the guide wire assists in accessing and navigating through blood vessels, particularly in complex vascular interventions.
Evidence Summary
The literature includes 14 studies, ranging from case reports to randomized controlled trials, published between 2013 and 2023. These studies explore various clinical applications and safety profiles of the device.
Reported Outcomes
Published studies report that the use of hydrophilic coating guide wires can significantly reduce the rate of central vein punctures and the incidence of pneumothorax. Additionally, they facilitate selective cannulation in ERCP procedures.
Safety Profile
Reported complications include fragmentation of the hydrophilic coating, which can lead to embolism in neuroendovascular therapy. Another study noted the risk of the guide wire becoming stuck during procedures.
Evidence Limitations
Evidence gaps include a limited understanding of the mechanisms behind polymer fragment formation. Further research is needed to explore long-term outcomes and safety in diverse patient populations.
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 hydrophilic coating guide wire?
The device is indicated for use in endovascular procedures, including embolization and neurovascular interventions.
What outcomes have been reported in clinical studies?
Studies have shown reduced central vein punctures and pneumothorax incidence, as well as improved cannulation success in ERCP.
What complications have been reported?
Safety data indicate risks of coating fragmentation leading to embolism and potential for the guide wire to become stuck during procedures.
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.