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Auryon Atherectomy Catheters
Product: Auryon Atherectomy Catheter — all models and sizes
Summary: The Auryon Atherectomy Catheters by Eximo Medical are used for the treatment of peripheral artery disease. Cleared via FDA 510k, they are designed to minimize procedural risks such as dissections and embolic events. Key evidence includes studies on clinical outcomes and safety.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K220116 ↗
Decision Date ?
September 26, 2022
Product Code ?
MCW Catheter, Peripheral, Atherectomy
Device Class ?
Class 2
Evidence ?
0 studies
The Auryon Atherectomy Catheters were cleared by the FDA via the 510k pathway on September 26, 2022. Manufactured by Eximo Medical, they are classified as Class 2 devices under product code MCW.
What It Is
The Auryon Atherectomy Catheters are medical devices used in atherectomy procedures to remove plaque from blood vessels, particularly in the lower limbs. They are designed to improve blood flow and reduce the risk of complications associated with peripheral artery disease.
FDA-Cleared Indications
- For atherectomy treatment of stenotic or occlusive lesions in peripheral arteries, based on the FDA device classification and product code.
- Intended for use during endovascular treatment of peripheral arterial disease in the lower-extremity circulation.
Clinical Applications
- Atherectomy of plaque in stenotic lower-extremity peripheral arteries.
- Treatment of peripheral arterial occlusions as part of an endovascular revascularization procedure.
- Plaque preparation before adjunctive balloon angioplasty or other indicated peripheral intervention.
- Use in selected patients with peripheral arterial disease when plaque removal or modification is needed before restoring blood flow.
Evidence Summary
The available literature includes three studies: one published in 2023 and two ongoing clinical trials. These studies encompass various methodologies, including a real-world setting analysis and post-market registry data.
Reported Outcomes
Published studies report that the Auryon Atherectomy System is effective in achieving desired clinical outcomes in the treatment of lower limb arterial stenosis. The system has shown promise in reducing procedural risks such as major dissections and embolic events.
Safety Profile
Reported complications include procedural risks such as dissections and embolic events, although the Auryon system is designed to minimize these. The studies reviewed did not provide detailed safety data, indicating a need for further research.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of detailed safety data. Further research is needed to fully understand the long-term efficacy and safety profile of the Auryon Atherectomy Catheters.
Practical Considerations
- The catheter must be used with the compatible Auryon atherectomy system and according to the current instructions for use.
- Lesion length, vessel diameter, calcification, tortuosity, access anatomy, and the catheter's available size must be assessed before treatment.
- Treatment is performed over wire access under fluoroscopic imaging, usually through femoral or another suitable arterial access site.
- Potential complications include vessel dissection, perforation, distal embolization, thrombosis, bleeding, and the need for adjunctive treatment.
- MRI safety depends on the specific catheter and whether it remains in the patient; consult the device labeling and institutional MRI policy rather than assuming it is MRI safe.
Frequently Asked Questions
What are the clinical indications for Auryon Atherectomy Catheters?
The Auryon Atherectomy Catheters are indicated for the treatment of peripheral artery disease, particularly in cases of stenosis or occlusion of the lower limb arteries.
What outcomes have been reported in clinical studies?
Studies report effective outcomes in reducing stenosis and improving blood flow, with a focus on minimizing procedural risks such as dissections and embolic events.
What complications have been reported?
Reported complications include procedural risks like dissections and embolic events, although the device is designed to minimize these occurrences.
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.