Diamondback 360 Peripheral Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of peripheral arterial disease in the peripheral vasculature.
• Modification of stenotic lesions, including severely calcified lesions, before or during endovascular treatment.
• Use in peripheral arteries that can accommodate the system's catheter and orbital atherectomy device.

Clinical Applications

• Plaque modification in calcified iliac and femoral artery disease before balloon angioplasty.
• Treatment preparation for calcified infrainguinal peripheral arterial lesions.
• Vessel preparation before placement of a peripheral stent when calcification limits balloon expansion.
• Treatment of peripheral arterial stenosis as part of an endovascular revascularization procedure.

Reported off-label uses

• Plaque modification of heavily calcified iliofemoral arteries to facilitate large-bore access for transcatheter aortic valve replacement.
• Treatment of selected calcified peripheral lesions in situations outside the device's specific labeled vessel or lesion criteria.

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 system is used over guidewire access under fluoroscopic imaging, usually through femoral or other percutaneous arterial access.
• Catheter size, guidewire compatibility, treated-vessel diameter, and lesion location must match the specific system configuration and current instructions for use.
• It is intended for plaque modification, not as a standalone replacement for angioplasty, stenting, bypass surgery, or medical therapy when those treatments are appropriate.
• Potential complications include dissection, perforation, embolization, thrombosis, spasm, bleeding, and distal ischemia; heavily calcified or tortuous vessels require careful device advancement and technique.
• MRI safety depends on the specific system components and whether any device remains in the patient; the current labeling should be checked before MRI.