Diamondback 360 Peripheral Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of de novo or restenotic lesions in peripheral arteries.
• Plaque modification in peripheral arterial lesions, including severely calcified lesions.
• Use in vessels with reference diameters within the device's labeled range and accessible through the approved catheter system.

Clinical Applications

• Plaque modification before balloon angioplasty in calcified peripheral artery disease.
• Preparation of peripheral arterial lesions before stent placement when indicated.
• Treatment of stenotic or occlusive lesions in lower-extremity peripheral arteries.
• Facilitation of peripheral arterial revascularization when calcium limits balloon expansion or device delivery.

Reported off-label uses

• Plaque modification in selected arterial beds or vessel sizes outside the device's specific labeling.
• Use in heavily calcified lesions to facilitate vascular access for structural heart procedures, such as transcatheter aortic valve replacement.

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 available with different catheter and crown configurations; the selected size must match the target vessel diameter and lesion location according to the current labeling.
• It is advanced over a guidewire through vascular access, commonly from the femoral or radial artery depending on the treatment territory and operator preference.
• Treatment requires fluoroscopic imaging and careful control of orbital speed, treatment time, and forward or backward movement to reduce the risk of vessel injury, perforation, embolization, or thrombosis.
• The device is intended for single-use catheter procedures and is not a permanent implant; it does not remain in the body after treatment.
• MRI safety and conditions depend on the specific system components and any other implanted devices. The current manufacturer's instructions for use and MRI labeling should be checked before scanning.