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Auryon Atherectomy Catheter 1 7mm Auryon Atherectomy Catheter 1 7mm Hydrophilic Coating
Product: Auryon Atherectomy Catheter — all models and sizes
Summary: The Auryon Atherectomy Catheter 1.7mm is a medical device used for removing plaque from blood vessels. It is primarily used by vascular surgeons and interventional radiologists.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K241553 ↗
Decision Date ?
June 27, 2024
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
419 studies
The Auryon Atherectomy Catheter 1.7mm, manufactured by Eximo Medical, was cleared through the FDA 510(k) pathway on June 27, 2024. It is classified as a Class 2 device.
What It Is
The Auryon Atherectomy Catheter 1.7mm is a specialized catheter used in atherectomy procedures to remove atherosclerotic plaque from blood vessels. It features a hydrophilic coating that enhances its maneuverability within the vascular system. This device is designed to improve blood flow by precisely targeting and removing blockages, thereby reducing the risk of embolization.
FDA-Cleared Indications
- Removal of plaque from peripheral arteries in patients with peripheral artery disease.
- Use in patients who require revascularization of narrowed or occluded peripheral arteries.
Clinical Applications
- Atherectomy during endovascular treatment of peripheral artery disease.
- Plaque removal from narrowed lower-extremity arteries.
- Treatment of peripheral arterial lesions when revascularization is indicated.
- Use by physicians during minimally invasive peripheral vascular interventions.
Practical Considerations
- The listed device is a 1.7 mm catheter with a hydrophilic coating; the catheter size and working length must match the target vessel, lesion, and access system.
- It is intended for peripheral vascular use and should be used with compatible guidewires, sheaths, imaging equipment, and other endovascular devices according to the instructions for use.
- The hydrophilic coating can improve catheter navigation, but careful handling is required to avoid coating damage and vascular injury.
- MRI safety and conditional-use information should be confirmed in the current manufacturer labeling; do not assume the device is MRI safe.
- Patient selection, contraindications, anticoagulation, embolic protection, and management of complications should follow the current instructions for use and standard peripheral intervention practice.
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 to improve blood flow.
What specialties typically use this device?
Vascular surgeons and interventional radiologists commonly use this device.
What are the FDA-cleared indications?
The device is indicated for the removal of plaque in patients with peripheral artery disease requiring revascularization.
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.