đź“Š Evidence-Based Reference
Hydrophilic Coated Guidewire
Summary: The hydrophilic coated guidewire by Lake Region Medical is used primarily in endovascular procedures. Key evidence highlights its application in reducing access site complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K133155 ↗
Decision Date ?
April 7, 2014
Product Code ?
DQX Wire, Guide, Catheter
Device Class ?
Class 2
Evidence ?
419 studies
The hydrophilic coated guidewire was cleared by the FDA through the 510(k) pathway on April 7, 2014. It is manufactured by Lake Region Medical and classified as a Class 2 device.
What It Is
The hydrophilic coated guidewire is a medical device designed to facilitate the navigation of catheters through blood vessels during endovascular procedures. Its hydrophilic coating reduces friction, aiding in smoother insertion and maneuverability.
FDA-Cleared Indications
- Used to facilitate the placement and navigation of catheters within the vascular system during diagnostic or interventional procedures.
- Intended for use by trained clinicians in endovascular procedures requiring guidewire support for catheter access.
Clinical Applications
- Vascular catheter placement and exchange
- Percutaneous coronary catheter procedures
- Cerebral and peripheral angiography
- Navigation through tortuous or difficult vascular anatomy
Evidence Summary
The available literature includes 15 studies, comprising randomized controlled trials, retrospective analyses, and case series, published between 2016 and 2023.
Reported Outcomes
Published studies report successful outcomes in catheter ablation of ventricular arrhythmias and reduced access site complications in radial artery procedures. The guidewire's hydrophilic coating is noted for improving procedural efficiency.
Safety Profile
Reported complications include perforation of small collateral branches during procedures, as noted in case reports. The overall complication rates vary depending on the procedural approach used.
Evidence Limitations
Current evidence is limited by the retrospective nature of some studies and the lack of large-scale randomized trials. Further research is needed to explore long-term outcomes and comparative effectiveness.
Practical Considerations
- Available in different diameters, lengths, tip shapes and stiffness levels; the selected wire must be compatible with the catheter and intended vascular anatomy.
- The hydrophilic coating becomes lubricious when adequately wetted with sterile fluid. The wire should be handled according to the manufacturer’s instructions to reduce coating damage and loss of control.
- Use requires fluoroscopic or other appropriate imaging guidance and careful attention to wire position, vessel injury and the risk of perforation or dissection.
- MRI safety depends on the exact model and labeling. Confirm MR conditions for the specific device before an MRI examination; do not assume that all guidewires are MRI safe.
- The wire is a temporary procedural device and is not intended to remain implanted after the procedure. Contraindications and warnings are described in the device-specific labeling.
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 coated guidewire?
The guidewire is indicated for use in endovascular procedures requiring catheter navigation, such as coronary interventions and cerebral angiography.
What outcomes have been reported in clinical studies?
Studies report successful elimination of ventricular arrhythmias and reduced access site complications with the use of this guidewire.
What complications have been reported?
Safety data indicate potential complications such as vessel perforation during procedures, with varying rates depending on the approach.
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.