đź“Š Evidence-Based Reference
hydrophilic guidewire
Lake Region Mfg.
Summary: The hydrophilic guidewire by Lake Region Mfg. is used primarily for navigating vascular pathways during minimally invasive procedures. Key evidence highlights its utility in various clinical scenarios, including neuroendovascular therapy and uterine artery embolization.
FDA Clearance Information
Pathway
510K
Number
K033758 ↗
Decision Date
December 19, 2003
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
The hydrophilic guidewire was cleared by the FDA via the 510(k) pathway on December 19, 2003. It is manufactured by Lake Region Mfg. and classified as a Class 2 medical device.
What It Is
The hydrophilic guidewire is a medical device designed to facilitate the navigation of vascular pathways during minimally invasive procedures. Its hydrophilic coating reduces friction, allowing for smoother passage through blood vessels.
Clinical Applications
Commonly used in procedures such as neuroendovascular therapy, uterine artery embolization, and transradial coronary angiography, the hydrophilic guidewire assists in the precise placement of catheters and other devices.
Evidence Summary
The literature includes 15 studies, comprising case series and other study types, published between 2022 and 2023. These studies explore various clinical applications and safety aspects of the hydrophilic guidewire.
Reported Outcomes
Published studies report successful use of the hydrophilic guidewire in facilitating catheter placement and reducing procedural complications. It has been effective in neuroendovascular therapy and uterine artery embolization, among other applications.
Safety Profile
Reported complications include polymer coating embolism during neuroendovascular therapy, which can lead to serious complications. Other studies highlight the potential for passage difficulty and branch injury during transradial procedures.
Evidence Limitations
The evidence is limited by the small size of some studies and the lack of large-scale randomized controlled trials. Further research is needed to fully understand the mechanisms of polymer fragment formation and to optimize safety protocols.
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 guidewire?
The hydrophilic guidewire is indicated for use in procedures requiring vascular navigation, such as neuroendovascular therapy and uterine artery embolization.
What outcomes have been reported in clinical studies?
Studies report successful catheter placement and reduced procedural complications in various applications, including neuroendovascular therapy and uterine artery embolization.
What complications have been reported?
Safety data indicate potential complications such as polymer coating embolism and passage difficulty during certain 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.