đź“Š Evidence-Based Reference
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Micro Therapeutics, Inc. D/B/A: Ev3
Summary: The Silverspeed Hydrophilic Guidewire is a medical device used primarily in endovascular procedures. Key evidence highlights its role in facilitating catheter advancement and its safety profile.
FDA Clearance Information
Pathway
510K
Number
K124007 ↗
Decision Date
March 7, 2013
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 March 7, 2013. It is manufactured by Micro Therapeutics, Inc. and is classified as a Class 2 device.
What It Is
The Silverspeed Hydrophilic Guidewire is designed to assist in the navigation and placement of catheters during endovascular procedures. Its hydrophilic coating reduces friction, allowing for smoother advancement through blood vessels.
Clinical Applications
This guidewire is commonly used in procedures such as neuroendovascular therapy, uterine artery embolization, and endoscopic retrograde cholangiography. It is particularly useful in scenarios requiring precise catheter placement.
Evidence Summary
The available literature includes a mix of RCTs, prospective, and retrospective studies, with a total of 10 studies reviewed. The studies span from 2022 to 2023, focusing on various clinical applications of hydrophilic guidewires.
Reported Outcomes
Published studies report that the Silverspeed Hydrophilic Guidewire effectively facilitates catheter advancement in endovascular procedures. It has been shown to improve procedural success rates in neurovascular and gynecological interventions.
Safety Profile
Reported complications include fragmentation of the hydrophilic coating, which may lead to embolism. However, the overall safety profile is considered acceptable when used as intended.
Evidence Limitations
Current evidence is limited by the small size of some studies and the lack of long-term follow-up data. Further research is needed to fully understand the mechanisms of coating fragmentation and its clinical implications.
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 endovascular procedures such as neuroendovascular therapy and uterine artery embolization.
What outcomes have been reported in clinical studies?
Studies report improved catheter advancement and procedural success rates in various interventions.
What complications have been reported?
Safety data indicates potential complications such as coating fragmentation leading to embolism.
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.