đź“Š Evidence-Based Reference
010 silverspeed hydropophilic guidewire 014 silversped hydrophilic guidewire 016 silverspeed hydrophilic guidewi
Micro Therapeutics
Summary: The Silverspeed Hydrophilic Guidewire is a device used primarily for embolization procedures. It is FDA-cleared and supported by 8 studies, highlighting its clinical utility in vascular interventions.
FDA Clearance Information
Pathway
510K
Number
K993257 ↗
Decision Date
October 21, 1999
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
The Silverspeed Hydrophilic Guidewire was cleared by the FDA via the 510(k) pathway on October 21, 1999. It is manufactured by Micro Therapeutics and classified as a Class 2 device under product code DQX.
What It Is
The Silverspeed Hydrophilic Guidewire is designed to facilitate the navigation of vascular systems during embolization procedures. Its hydrophilic coating enhances maneuverability through tortuous vessels, making it suitable for complex vascular interventions.
Clinical Applications
This guidewire is commonly used in procedures involving embolization of vascular disorders, particularly where precise navigation through intricate vascular pathways is required. It is often employed in interventional radiology and cardiology settings.
Evidence Summary
The available literature includes 8 studies, comprising various study types such as RCTs and case series, conducted between 2012 and 2025. These studies provide insights into the device's efficacy and safety in clinical practice.
Reported Outcomes
Published studies report that the Silverspeed Hydrophilic Guidewire is effective in facilitating complex vascular interventions, with successful outcomes in embolization procedures. The device's hydrophilic properties are noted to improve procedural efficiency and accuracy.
Safety Profile
Reported complications include potential risks associated with vascular interventions, such as vessel perforation or dissection. However, the studies reviewed did not highlight any significant safety concerns specific to the guidewire itself.
Evidence Limitations
The evidence base is limited by the small sample sizes and the heterogeneity of study designs. Further research is needed to establish long-term outcomes and to compare the guidewire's performance with alternative devices.
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 Silverspeed Hydrophilic Guidewire?
The guidewire is indicated for use in embolization procedures, particularly in navigating complex vascular pathways during interventional radiology and cardiology procedures.
What outcomes have been reported in clinical studies?
Clinical studies have reported successful navigation and embolization outcomes, with improved procedural efficiency due to the guidewire's hydrophilic properties.
What complications have been reported?
Safety data from evidence indicate potential complications such as vessel perforation or dissection, though no significant device-specific safety concerns were noted.
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.