Silverhawk Peripheral Plaque Excision System Turbohawk Peripheral Plaque Excision System

FDA-Cleared Indications

• Removal of atherosclerotic plaque from peripheral arteries.
• Treatment of peripheral arterial lesions in patients with peripheral artery disease.
• Use in infrainguinal peripheral arteries when plaque excision is clinically appropriate.

Clinical Applications

• Directional atherectomy of femoropopliteal peripheral arterial lesions.
• Plaque removal in selected peripheral arteries causing symptomatic arterial narrowing.
• Endovascular treatment of peripheral artery disease in patients with claudication or limb-threatening ischemia when plaque excision is indicated.
• Lesion preparation before or alongside other endovascular treatments, such as balloon angioplasty, when consistent with the device labeling and treatment plan.

Reported off-label uses

• Use in peripheral arterial segments or lesion types outside the device-specific cleared labeling may occur in clinical practice, but this is off-label and should be determined by the treating physician.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The catheter size and working length must match the target vessel, lesion characteristics, guidewire, sheath, and compatible imaging equipment.
• Treatment is performed under fluoroscopic imaging through vascular access, commonly from the common femoral artery; local anesthesia with moderate sedation or other anesthesia may be used.
• The device removes plaque into a collection chamber that may require emptying during the procedure; careful device advancement and cutter orientation are important.
• Potential complications include distal embolization, vessel dissection or perforation, thrombosis, bleeding at the access site, contrast reaction, kidney injury, and need for additional treatment.
• MRI safety depends on the specific device components and whether they remain in the patient. The catheter is generally removed after treatment; patients should verify the exact model and labeling before MRI.