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auryon atherectomy system
Eximo Medical
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
510K
Number
K202835 ↗
Decision Date
December 2, 2020
Product Code
MCW
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.
Clinical Applications
Commonly used in the treatment of peripheral artery disease, the Auryon Atherectomy System is particularly effective for patients with chronic limb-threatening ischemia and heavily calcified lesions.
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.
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.