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auryon atherectomy system
Eximo Medical
Summary: The Auryon Atherectomy System is a laser-based device used for atherectomy procedures, primarily in treating peripheral artery disease. Key evidence shows high procedural success and patency rates in below-the-knee arteries.
FDA Clearance Information
Pathway
510K
Number
K230709 ↗
Decision Date
June 9, 2023
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, 2023. It is manufactured by Eximo Medical and classified as a Class 2 medical device.
What It Is
The Auryon Atherectomy System is a laser-based device designed for the removal of atherosclerotic plaque from blood vessels. It utilizes a 355 nm laser to treat peripheral artery disease, particularly in the lower extremities.
Clinical Applications
Commonly used in patients with chronic limb-threatening ischemia, the Auryon Atherectomy System is applied in scenarios requiring precise plaque removal in below-the-knee arteries. It is also used in complex coronary artery lesion preparation.
Evidence Summary
The literature includes 12 studies, comprising prospective and retrospective designs, with data collected from 2023 to 2025. These studies evaluate the efficacy and safety of the Auryon system 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 Auryon system has demonstrated effectiveness in treating infrapopliteal arterial disease with high procedural success.
Safety Profile
Reported complications include a low incidence of major adverse limb events and postoperative death, with none reported 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 small sample sizes and short follow-up durations in some studies. Further research is needed to evaluate long-term outcomes and the device's effectiveness in broader 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% in below-the-knee arteries.
What complications have been reported?
Safety data indicate a low incidence of major adverse limb events and postoperative death, 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.