Diamondback 360 Orbital Atherectomy System Stealth 360 Orbital Pad System

FDA-Cleared Indications

• Treatment of de novo and restenotic lesions in peripheral arteries.
• Treatment of calcified lesions in the peripheral vasculature to facilitate balloon angioplasty or stent placement.
• Use in peripheral arteries with reference vessel diameters within the limits specified in the device labeling.

Clinical Applications

• Atherectomy of calcified peripheral arterial lesions before balloon angioplasty.
• Lesion preparation before peripheral vascular stent placement.
• Treatment of severely calcified peripheral artery disease when balloon angioplasty alone may not adequately expand the vessel.
• Modification of plaque in selected lower-extremity peripheral arteries according to the specific system and catheter labeling.

Reported off-label uses

• Coronary orbital atherectomy is used in clinical practice with coronary-specific versions of the Diamondback system, but the 2011 clearance identified here is for the peripheral system and should not be assumed to cover coronary use.
• Treatment of heavily calcified dialysis access lesions has been reported in clinical practice, but this is not necessarily covered by the peripheral labeling and should be evaluated against the current device instructions.

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 different catheter sizes and crown configurations; the selected catheter must match the target vessel diameter and the current instructions for use.
• It is advanced over a compatible guidewire through vascular access, commonly from the femoral or radial artery depending on the treatment site and operator approach.
• The operator uses fluoroscopic imaging and controlled rotational advancement; prolonged treatment in one location can increase the risk of vessel injury, embolization, or slow flow.
• Contraindications and warnings include unsuitable vessel anatomy, severe dissection, acute thrombus, inability to cross the lesion, and other conditions listed in the current labeling.
• MRI safety depends on the specific catheter and whether it remains in the body; the device should be removed after treatment, and the current manufacturer MRI instructions should be checked before scanning.