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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 for atherectomy procedures. It is primarily used to treat peripheral arterial disease, particularly in below-the-knee arteries. Key evidence shows high procedural success and patency rates.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K221077 ↗
Decision Date ?
June 9, 2022
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Auryon Atherectomy System was cleared by the FDA via the 510(k) pathway on June 9, 2022. It is manufactured by Eximo Medical and classified as a Class 2 device.
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 precisely ablate plaque, making it suitable for treating complex lesions in peripheral arterial disease.
FDA-Cleared Indications
- Treatment of stenotic or occlusive lesions in peripheral arteries using laser atherectomy.
- Use in peripheral vasculature, including below-the-knee arteries, when the lesion and vessel size meet the device labeling.
- Intended for use by physicians trained in endovascular procedures and laser atherectomy.
Clinical Applications
- Laser atherectomy of peripheral arterial stenosis or occlusion.
- Plaque modification before or during balloon angioplasty in peripheral arteries.
- Treatment of selected infrapopliteal, or below-the-knee, peripheral arterial lesions.
- Endovascular treatment of atherosclerotic peripheral artery disease when the anatomy is suitable for the labeled catheter.
Reported off-label uses
- Use in peripheral arterial lesions or clinical situations outside the specific vessel, lesion, or patient criteria in the device labeling may occur in practice, but this is off-label and should be determined by the treating physician.
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, retrospective, and randomized controlled trials. These studies span from 2023 to 2025 and evaluate the device's efficacy and safety in various clinical settings.
Reported Outcomes
Published studies report a procedure success rate of 63.8% and a 30-day patency rate of 88.9% in below-the-knee arteries. The device has shown high procedural success in treating infrapopliteal arterial disease in patients with chronic limb-threatening ischemia.
Safety Profile
Reported complications include a low rate of major adverse limb events and no postoperative deaths at 30 days. Bailout stenting was required in 1.6% of cases, indicating a favorable safety profile.
Evidence Limitations
Current evidence is limited by the relatively small sample sizes and short follow-up periods in some studies. Further research is needed to evaluate long-term outcomes and effectiveness in diverse patient populations.
Practical Considerations
- The system uses a 355-nanometer laser catheter; the appropriate catheter size and working length must match the target vessel, access route, and lesion.
- It is used with fluoroscopic imaging and requires compatible guidewires, sheaths, and other accessories specified in the instructions for use.
- Laser atherectomy requires training in endovascular technique and management of complications such as embolization, perforation, dissection, thrombosis, and distal embolization.
- MRI safety depends on the specific catheter and system components. Confirm the current labeling before MRI; do not assume the device is MRI safe or MR conditional.
- The system is not a permanent implant. It is used during the procedure and removed afterward; other treatment such as angioplasty, stenting, medication, or surgery may still be needed.
Frequently Asked Questions
What are the clinical indications for Auryon Atherectomy System?
The device is indicated for the treatment of peripheral arterial disease, particularly in below-the-knee arteries, and for complex coronary lesions.
What outcomes have been reported in clinical studies?
Studies report a procedure success rate of 63.8% and a 30-day patency rate of 88.9% in below-the-knee arteries.
What complications have been reported?
Reported complications include a low rate 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.