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hydrophilic coated guidewire
Lake Region Mfg.
Summary: The hydrophilic coated guidewire by Lake Region Mfg. is primarily used in embolization procedures. Key evidence highlights its role in reducing access site complications.
FDA Clearance Information
Pathway
510K
Number
K981667 ↗
Decision Date
June 5, 1998
Product Code
KNY
Device Class
Class 2
Evidence
419 studies
The hydrophilic coated guidewire was cleared by the FDA via the 510(k) pathway on June 5, 1998. It is manufactured by Lake Region Mfg. 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 the vascular system. It is used in various endovascular procedures, particularly for embolization.
Clinical Applications
This guidewire is commonly used in procedures requiring precise catheter placement, such as embolization of vascular lesions and interventions involving complex vascular anatomy.
Evidence Summary
The literature includes 15 studies, comprising randomized controlled trials, retrospective analyses, and case series, spanning from 2016 to 2023. These studies explore the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report successful outcomes in catheter manipulation and embolization procedures. For instance, a study on catheter ablation reported an 83.74% success rate in eliminating ventricular arrhythmias. The guidewire's role in reducing access site complications is also noted.
Safety Profile
Reported complications include perforation of vascular structures, as seen in a case of brachiocephalic artery perforation. Other studies noted complications rates of 3.25% to 8.86% depending on the approach used.
Evidence Limitations
Current evidence is limited by the retrospective nature of many studies and the variability in study designs. Further research is needed to establish long-term safety and efficacy across 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 coated guidewire?
The guidewire is indicated for use in embolization procedures and other interventions requiring precise catheter navigation through the vascular system.
What outcomes have been reported in clinical studies?
Studies report high success rates in catheter manipulation and embolization, with significant reductions in access site complications.
What complications have been reported?
Safety data indicate risks of vascular perforation and other complications, with rates varying based on procedural 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.