Diamonback 360 Peripheral Orbital Atherectomy System Diamondback 360 Stealth Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of peripheral arterial disease in the lower-extremity vasculature.
• Modification of stenotic lesions, including severely calcified lesions, before or during percutaneous peripheral intervention.
• Use in peripheral arteries with reference-vessel diameters appropriate for the specific cleared catheter and crown size.

Clinical Applications

• Plaque modification in calcified iliac, femoropopliteal, and infrapopliteal peripheral artery lesions.
• Preparation of peripheral arterial lesions before balloon angioplasty or stent placement.
• Treatment of stenotic lesions in patients with symptomatic lower-extremity peripheral artery disease when endovascular revascularization is planned.
• Facilitation of endovascular access through selected calcified peripheral arterial segments when consistent with the device labeling and treatment plan.

Reported off-label uses

• Use in selected coronary artery lesions is outside the peripheral indication and should not be inferred from this FDA clearance.
• Use in vessels or lesion types outside the labeled anatomy, including nonvascular applications, is off-label.

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 and crown configurations; the selected size must match the target vessel diameter and lesion anatomy according to the current instructions for use.
• The device is advanced over a guidewire through vascular access, commonly from the common femoral artery, with fluoroscopic guidance and continuous saline infusion during operation.
• It is generally used with local anesthesia and moderate sedation, although anesthesia needs vary by patient and procedure. Atherectomy is usually followed by balloon angioplasty and may be followed by stent placement.
• The system is not an MRI device during placement or use. MRI eligibility after treatment depends on any implanted stent or other device used; the applicable implant-specific MRI conditions must be followed.
• Potential complications include vessel perforation or dissection, embolization, thrombosis, bleeding at the access site, distal ischemia, contrast-related complications, and the need for additional treatment. Contraindications and warnings in the current manufacturer labeling should be reviewed before use.