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Auryon Atherectomy System
Product: Auryon Atherectomy Catheter 1.5 mm OTW — all models and sizes
Summary: The Auryon Atherectomy System is a laser-based device used primarily for treating peripheral artery disease, including below-the-knee lesions. Key evidence shows high procedural success and patency rates with minimal complications.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K202835 ↗
Decision Date ?
December 2, 2020
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Auryon Atherectomy System was cleared via the FDA 510(k) pathway on December 2, 2020. Manufactured by Eximo Medical, it is classified as a Class 2 device under product code MCW.
What It Is
The Auryon Atherectomy System is a laser-based device designed for the removal of atherosclerotic plaque from peripheral arteries. It utilizes a 355 nm laser to treat various lesion morphologies, particularly in below-the-knee arteries.
FDA-Cleared Indications
- Treatment of peripheral vascular lesions with laser atherectomy.
- Use in peripheral arteries, including below-the-knee arteries, when plaque modification or removal is clinically indicated.
- Use with compatible guidewires and other endovascular devices as specified in the system's labeling.
Clinical Applications
- Laser atherectomy of atherosclerotic lesions in peripheral arteries.
- Treatment of selected femoropopliteal peripheral artery disease lesions.
- Treatment of selected below-the-knee peripheral artery disease lesions.
- Plaque preparation before adjunctive balloon angioplasty or other endovascular therapy when indicated.
Reported off-label uses
- Use in selected peripheral arterial lesions or lesion morphologies outside the device's specific labeled indications may be reported in clinical practice, but this should be evaluated by an experienced physician and is not an FDA-cleared use.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
Evidence Summary
The available literature includes 12 studies, comprising prospective and retrospective designs, with data collected from 2023 to 2025. These studies evaluate the device's efficacy and safety in treating peripheral artery disease.
Reported Outcomes
Published studies report a procedure success rate of 63.8% and a 30-day patency rate of 88.9% in treating below-the-knee arteries. The Auryon laser has demonstrated effectiveness in managing chronic limb-threatening ischemia with minimal need for bailout stenting.
Safety Profile
Reported complications include a low incidence of major adverse limb events and no postoperative deaths at 30 days. Bailout stenting was required in only 1.6% of cases, indicating a favorable safety profile.
Evidence Limitations
Current evidence is limited by the small sample sizes and short follow-up durations in some studies. Further research is needed to assess long-term outcomes and effectiveness in diverse patient populations.
Practical Considerations
- The system uses a 355-nm laser catheter and must be used with the compatible console, accessories, guidewire, and catheter sizes specified in the current instructions for use.
- Lesion assessment is important because severe calcification, chronic total occlusion characteristics, vessel diameter, tortuosity, and distal runoff can affect procedural feasibility and risk.
- Treatment is performed under fluoroscopic imaging, commonly through femoral or radial arterial access depending on the target anatomy and operator preference, with local anesthesia and possible conscious sedation.
- Atherectomy may be followed by balloon angioplasty, stenting, drug-coated balloon treatment, or surgery when clinically necessary; it does not replace medical therapy or revascularization planning.
- MRI safety depends on the specific Auryon components and whether they remain in the patient. The current manufacturer labeling should be checked before MRI; do not assume the system or a treated vessel is universally MRI safe.
Frequently Asked Questions
What are the clinical indications for Auryon Atherectomy System?
The Auryon Atherectomy System is indicated for the treatment of peripheral artery disease, particularly in below-the-knee arteries in patients with chronic limb-threatening ischemia.
What outcomes have been reported in clinical studies?
Clinical studies have reported a procedure success rate of 63.8% and a 30-day patency rate of 88.9% for below-the-knee treatments.
What complications have been reported?
Safety data indicate a low incidence of major adverse limb events and no postoperative deaths at 30 days, with bailout stenting required in 1.6% of cases.
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.