Diamondback 360 Peripheral Orbital Atherectomy System Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series Stealth 360 Peripheral Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of peripheral vascular disease involving stenotic or occluded peripheral arteries.
• Modification of stenotic or occlusive material, including calcified plaque, before or during endovascular treatment.
• Use in peripheral vessels that can accommodate the device according to the labeled size and access requirements.

Clinical Applications

• Plaque modification before balloon angioplasty in calcified peripheral arterial disease.
• Preparation of peripheral arterial lesions for other endovascular revascularization procedures.
• Treatment of calcified lesions in lower-extremity peripheral arteries when atherectomy is clinically appropriate.
• Use through an endovascular catheter system under fluoroscopic imaging.

Reported off-label uses

• Plaque modification in selected arterial beds or lesion types outside the device's specific labeling may be reported in clinical practice, but this should be considered off-label and requires individualized specialist judgment.

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 access sheath or catheter and requires fluoroscopic guidance; access is commonly obtained through the femoral or radial artery depending on the treatment plan.
• Available catheter and crown configurations have specific vessel-diameter, lesion-length, guidewire, sheath, and compatibility requirements. The current instructions for use should be checked before treatment.
• Orbital atherectomy removes or modifies plaque but may be followed by balloon angioplasty, stenting, or another revascularization technique when residual narrowing remains.
• Important risks include embolization, vessel dissection or perforation, thrombosis, distal ischemia, bleeding at the access site, contrast reactions, kidney injury, and need for additional treatment.
• MRI safety depends on the exact components and whether the device remains in the patient. The system is generally intended for single-use procedural treatment; the product labeling should be reviewed before MRI or reuse.