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auryon atherectomy catheter 1 7mm auryon atherectomy catheter 1 7mm hydrophilic coating
Eximo Medical
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
510K
Number
K241553 ↗
Decision Date
June 27, 2024
Product Code
MCW
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.
Clinical Applications
This device is commonly used in peripheral artery disease (PAD) interventions, particularly in patients with significant plaque buildup in the lower extremities. Vascular surgeons and interventional radiologists utilize it in both hospital and outpatient settings. It is suitable for patients who are candidates for minimally invasive procedures to restore blood flow and alleviate symptoms such as claudication.
Indications for Use
The FDA indications for the Auryon Atherectomy Catheter include the removal of plaque in patients with peripheral artery disease. It is intended for use in patients who require revascularization of occluded or narrowed peripheral arteries.
Practical Considerations
The Auryon Atherectomy Catheter is typically available in a 1.7mm size, making it suitable for small to medium-sized vessels. Its hydrophilic coating aids in smooth navigation through tortuous anatomy. Clinicians should ensure compatibility with other endovascular tools and consider the catheter's length relative to the target lesion.
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.