Diamondback 360 Peripheral Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of peripheral vascular disease in patients with stenotic or occlusive lesions.
• Plaque modification in peripheral arteries to facilitate subsequent percutaneous revascularization.
• Use in peripheral vessels appropriate for the device's labeled catheter and guidewire compatibility.

Clinical Applications

• Plaque modification before balloon angioplasty in heavily calcified peripheral arterial lesions.
• Preparation of peripheral arterial lesions before stent placement when additional plaque modification is needed.
• Treatment of calcified lesions associated with lower-extremity peripheral artery disease.
• Use during catheter-based peripheral revascularization when lesion calcification limits balloon passage or expansion.

Reported off-label uses

• Plaque modification to facilitate alternative large-bore arterial access, including access considered for transcatheter aortic valve replacement, when performed outside the device labeling.
• Use in selected critical limb ischemia cases beyond the specific anatomy or indications described in the cleared 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 delivered through a vascular sheath and guidewire, with the catheter size selected according to the target vessel diameter and lesion anatomy.
• Treatment requires fluoroscopic imaging and careful advancement, activation, and withdrawal of the orbital atherectomy catheter; operators must follow the manufacturer's instructions for use.
• Potential complications include arterial perforation or dissection, distal embolization, thrombosis, vasospasm, bleeding, and the need for additional intervention.
• MRI safety depends on the specific catheter and whether any component remains in the patient; the device should not be considered automatically MRI safe. Review the current labeling before MRI.
• Treatment may be inappropriate or require special precautions in vessels that are too small, severely tortuous, acutely thrombosed, or otherwise outside the labeled anatomy. It does not replace medication, balloon angioplasty, stenting, or open surgery when those treatments are more appropriate.