Diamondback 360 Peripheral Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of stenotic lesions in peripheral arteries caused by atherosclerotic disease.
• Modification of calcified plaque before or during peripheral vascular intervention.
• Use in peripheral arteries that can accommodate the system's indicated catheter size and guidewire requirements.

Clinical Applications

• Plaque modification before balloon angioplasty in peripheral arterial disease.
• Treatment of calcified lesions in the iliac, femoropopliteal, and below-the-knee peripheral arterial circulation when the specific device configuration is indicated.
• Lesion preparation before placement of a peripheral vascular stent when additional plaque modification is needed.
• Treatment of peripheral arterial stenosis as part of an endovascular revascularization procedure.

Reported off-label uses

• Use in selected vascular-access lesions to facilitate large-bore access for procedures such as transcatheter aortic valve replacement; this application should be evaluated by the treating specialist because it may not match the device labeling.

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 a compatible guidewire through an appropriately sized vascular sheath or catheter, with fluoroscopic imaging and contrast angiography typically used for positioning.
• Available catheter configurations and vessel-size requirements vary; the operator must confirm the specific model's compatibility with the target vessel, guidewire, and access system.
• Orbital atherectomy requires controlled device advancement and treatment runs; excessive force, prolonged treatment, or inappropriate speed can increase the risk of vessel injury or embolization.
• Contraindications and precautions include unsuitable vessel anatomy, severe dissection or perforation, inability to cross the lesion safely, thrombus or significant uncontrolled bleeding risk, and other conditions listed in the device instructions for use.
• MRI safety depends on the exact component and whether it remains in the patient. The device is generally removed after the procedure; patients should provide the implant or procedure record to the MRI team before scanning.