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mirage hydrophilic guidewire x-pedion hydrophilic guidewire
Micro Therapeutics Inc., D/B/A Ev3 Neurovascular
Summary: The Mirage and X-Pedion hydrophilic guidewires are used in neurovascular procedures to aid in the delivery of embolization agents. They are primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway
510K
Number
K193548 ↗
Decision Date
January 18, 2020
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
The Mirage and X-Pedion hydrophilic guidewires were cleared through the FDA 510(k) pathway on January 18, 2020, by Micro Therapeutics Inc., D/B/A Ev3 Neurovascular. They are classified as Class 2 devices.
What It Is
The Mirage and X-Pedion guidewires are hydrophilic-coated devices designed to facilitate the navigation of complex vascular pathways, particularly in neurovascular procedures. Their hydrophilic coating reduces friction, allowing for smoother passage through tortuous vessels. These guidewires are essential tools in minimally invasive procedures, providing support and direction for catheters used in embolization and other vascular interventions.
Clinical Applications
These guidewires are commonly used in neurointerventional procedures, such as the treatment of cerebral aneurysms and arteriovenous malformations. They are utilized in hospital settings, particularly in interventional radiology and neurosurgery departments. The guidewires are suitable for adult and pediatric patients requiring precise navigation within the cerebral vasculature.
Indications for Use
The FDA-cleared indications for these guidewires involve their use in delivering embolization agents to treat vascular abnormalities. They are intended for patients with conditions such as aneurysms, where precise placement of therapeutic agents is crucial.
Practical Considerations
These guidewires are available in various lengths and diameters to accommodate different vascular anatomies. Compatibility with a range of catheters is essential, and clinicians should be familiar with the specific techniques for handling hydrophilic-coated devices to prevent damage or loss of coating.
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 is the Mirage & X-Pedion guidewire used for?
They are used to navigate complex vascular pathways during neurovascular procedures, aiding in the delivery of embolization agents.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use these guidewires in neurovascular interventions.
What are the FDA-cleared indications?
They are indicated for use in delivering embolization agents to treat vascular abnormalities like aneurysms and arteriovenous malformations.
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.