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Auryon Atherectomy Catheter 1 5 Mm XL Hydrophilic Coating Exm-4010-H000 Auryon Atherectomy Catheter 0 9 Mm XL Hydrophilic Coating Exm-4011-H000 Auryon Atherectomy Catheter 1 5 Mm XL Exm -4010-0000 Auryon Atherectomy Catheter 0 9 Mm XL Exm-4011-0000
Product: Auryon Atherectomy Catheter — all models and sizes
Summary: The Auryon Atherectomy Catheter is a medical device used for removing plaque from blood vessels. It is primarily used by vascular surgeons and interventional radiologists to treat peripheral artery disease.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K233668 ↗
Decision Date ?
December 15, 2023
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
419 studies
The Auryon Atherectomy Catheter, manufactured by Eximo Medical, was cleared through the FDA 510(k) pathway on December 15, 2023. It is classified as a Class 2 medical device.
What It Is
The Auryon Atherectomy Catheter is a minimally invasive device designed to remove atherosclerotic plaque from peripheral arteries. It employs laser technology to precisely ablate plaque, improving blood flow. The catheter comes with a hydrophilic coating to ease navigation through the vasculature, reducing friction and potential vessel trauma.
FDA-Cleared Indications
- Atherectomy of stenotic or occlusive lesions in peripheral arteries.
- Use in patients with peripheral arterial disease when plaque removal is clinically indicated.
- Available catheter configurations include 0.9 mm and 1.5 mm tip sizes, with hydrophilic-coated and non-coated versions.
Clinical Applications
- Laser atherectomy of peripheral arterial plaque.
- Treatment of peripheral arterial stenosis or occlusion during an endovascular procedure.
- Plaque modification before or in combination with balloon angioplasty or other peripheral vascular interventions.
- Treatment of lesions in appropriately sized peripheral vessels under fluoroscopic guidance.
Practical Considerations
- The listed configurations include 0.9 mm and 1.5 mm XL catheters, with either a hydrophilic coating or no hydrophilic coating.
- The catheter is used through an appropriately sized vascular sheath or guide catheter and must be compatible with the clinician's access system and other endovascular equipment.
- Hydrophilic-coated versions may reduce friction during advancement but require appropriate wetting and handling according to the instructions for use.
- The procedure requires fluoroscopic imaging and operators trained in peripheral laser atherectomy. Vessel diameter, lesion characteristics, wire position and distal embolization risk must be assessed before treatment.
- MRI safety should be confirmed in the current manufacturer labeling for the specific catheter and clinical situation. A catheter that remains in the body is not automatically considered MRI safe.
Related Literature
The linked study compared the Auryon Atherectomy System combined with standard balloon angioplasty to balloon angioplasty alone. While the abstract is unavailable, such studies typically assess efficacy in plaque removal and improvement in vessel patency. Limitations might include sample size and lack of long-term outcomes.
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 Auryon Atherectomy Catheter used for?
It is used for removing plaque from peripheral arteries in patients with peripheral artery disease.
What specialties typically use this device?
Vascular surgeons and interventional radiologists typically use this device.
What are the FDA-cleared indications?
It is indicated for the removal of plaque in peripheral arteries in patients with peripheral artery disease.
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.