đź“‹ FDA Reference
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 by interventional radiologists and neurosurgeons for navigating vascular systems during embolization procedures. They are essential tools for accessing difficult-to-reach areas within the vasculature.
FDA Clearance Information
Pathway
510K
Number
K201690 ↗
Decision Date
July 21, 2020
Product Code
DQX
Device Class
Class 2
Evidence
419 studies
The Mirage and X-Pedion guidewires were cleared through the FDA 510(k) pathway on July 21, 2020. Manufactured by Micro Therapeutics Inc., D/B/A Ev3 Neurovascular, these devices are classified as Class 2 under product code DQX.
What It Is
The Mirage and X-Pedion hydrophilic guidewires are medical devices designed to assist in the navigation of complex vascular systems. They feature a hydrophilic coating that reduces friction, allowing for smoother passage through blood vessels. These guidewires are particularly useful in procedures requiring precise control and access to challenging anatomical locations.
Clinical Applications
These guidewires are commonly used in endovascular procedures, particularly in the fields of interventional radiology and neurosurgery. They are employed in the treatment of conditions such as aneurysms and arteriovenous malformations, where precise navigation and placement of embolic agents are crucial. The devices are suitable for use in both hospital and outpatient settings, catering to adult and pediatric patient populations.
Indications for Use
The FDA indications suggest that these guidewires are intended for use in procedures involving the delivery of embolization agents. They are suitable for patients requiring treatment of vascular abnormalities, such as aneurysms, where precise navigation within the vasculature is necessary.
Practical Considerations
These guidewires are available in various sizes to accommodate different vascular anatomies and procedural requirements. They are compatible with a range of catheters and embolic agents, making them versatile tools in endovascular interventions. Clinicians should be familiar with the hydrophilic coating's handling characteristics to optimize performance during procedures.
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 Mirage & X-Pedion guidewires used for?
They are used for navigating vascular systems during embolization procedures, particularly in treating aneurysms and arteriovenous malformations.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use these guidewires in endovascular procedures.
What are the FDA-cleared indications?
These guidewires are indicated for use in procedures involving the delivery of embolization agents to treat vascular abnormalities.
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.