Diamondback 360 Peripheral Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of stenotic peripheral arteries with the intent to facilitate revascularization.
• Treatment of calcified lesions in peripheral arteries by plaque modification using orbital atherectomy.
• Use in peripheral arterial vessels appropriate for the specific catheter size and labeled device configuration.

Clinical Applications

• Plaque modification before balloon angioplasty in calcified peripheral arterial disease.
• Treatment preparation for stenotic lesions in lower-extremity peripheral arteries.
• Facilitation of peripheral arterial revascularization when calcium limits balloon expansion or device passage.
• Use during endovascular treatment of peripheral arterial lesions selected according to the device labeling.

Reported off-label uses

• Use in coronary arteries or other vascular beds outside the labeled peripheral indication may be described in clinical practice for orbital atherectomy devices, but it is not an on-label use of this peripheral system.

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 includes a specialized atherectomy catheter and drive unit; catheter diameter, guidewire requirements, and treated-vessel size depend on the specific configuration.
• The catheter is advanced over a compatible guidewire under fluoroscopic imaging, and the operator uses short treatment runs with saline infusion according to the instructions for use.
• Potential complications include vessel dissection or perforation, thrombosis, distal embolization, spasm, bleeding, and access-site complications.
• It is not a replacement for all forms of revascularization; medication, balloon angioplasty, stenting, bypass surgery, or other atherectomy techniques may be appropriate depending on the lesion.
• MRI safety depends on the exact catheter and system components and their condition. The device should not be assumed to be MRI safe; consult the current manufacturer labeling before MRI.