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auryon atherectomy system
Eximo Medical
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
510K
Number
K221077 ↗
Decision Date
June 9, 2022
Product Code
MCW
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.
Clinical Applications
The device is commonly used in the treatment of peripheral arterial disease, particularly in below-the-knee arteries in patients with chronic limb-threatening ischemia. It is also used in cases of acute limb ischemia and heavily calcified coronary lesions.
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.
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.