Auryon Atherectomy System
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FDA Clearance Information
FDA-Cleared Indications
- Treatment of lesions in peripheral arteries affected by stenosis or occlusion.
- Use in adult patients requiring atherectomy as part of endovascular treatment for peripheral arterial disease.
- Removal or modification of atherosclerotic plaque to help restore or improve blood flow in the treated peripheral vessel.
Clinical Applications
- Atherectomy of stenotic peripheral arteries caused by atherosclerotic plaque.
- Treatment of peripheral arterial disease in lower-extremity arteries.
- Lesion preparation before balloon angioplasty or stent placement.
- Treatment of selected calcified, fibrotic, or otherwise difficult peripheral arterial lesions when atherectomy is part of the endovascular strategy.
Practical Considerations
- The system is intended for peripheral arterial use; the exact cleared vessel sizes, catheter sizes, guidewire requirements, and lesion characteristics depend on the specific catheter and current labeling.
- It is generally used through percutaneous vascular access, commonly the femoral artery, with fluoroscopic imaging and a compatible guidewire.
- Atherectomy may be followed by balloon angioplasty, drug-coated balloon treatment, or stenting when clinically appropriate; embolic protection or aspiration may be considered in selected cases.
- Patients with severe contrast allergy, bleeding risk, infection at the access site, or anatomy that cannot safely accommodate the device require individualized assessment.
- MRI safety and conditional-use requirements should be checked in the current device labeling and institutional MRI policy before scanning; the catheter is not left implanted after treatment.
Procedures that use this device
Frequently Asked Questions
What is the Auryon Atherectomy System used for?
It is used to remove or modify atherosclerotic plaque in narrowed peripheral arteries, most often in the legs. It may be followed by angioplasty or stent placement to improve blood flow.
Is the Auryon Atherectomy System MRI safe?
The treatment catheter is not permanently implanted, but MRI conditions depend on the specific device components and labeling. The current instructions for use and the MRI department's policy should be reviewed before scanning.
What sizes are available for the Auryon system?
Auryon catheters are available in different sizes for selected peripheral vessel and lesion anatomies. The appropriate catheter and guidewire size must be confirmed in the current FDA-cleared labeling.
How long does the Auryon Atherectomy System last?
The catheter is a single-use device and is removed after the procedure. Any improvement in circulation depends on the treated artery, plaque burden, additional treatment, and progression of peripheral arterial disease.
How much does the Auryon Atherectomy System cost?
The device price is generally not published as a fixed patient charge. Total cost depends on the hospital, physician and facility fees, imaging, anesthesia or sedation, additional devices, and insurance coverage.