Diamondback 360 Degree Orbital Atherectomy System

FDA-Cleared Indications

• Atherectomy of peripheral arterial lesions that are stenotic or occlusive and contain calcified plaque.
• Treatment of de novo or restenotic peripheral artery lesions when plaque modification is needed before or instead of balloon angioplasty.
• Use in coronary arteries for treatment of severely calcified lesions when the specific system configuration is cleared for coronary atherectomy.

Clinical Applications

• Plaque modification in calcified peripheral arterial disease before balloon angioplasty or stent placement.
• Treatment of calcified lesions in lower-extremity arteries, including iliac, femoral, popliteal and infrapopliteal segments when covered by the device labeling.
• Plaque modification in severely calcified coronary lesions with a coronary-labeled Diamondback 360 system.
• Creation of a more compliant vessel lumen to facilitate subsequent balloon delivery or expansion in selected calcified lesions.

Reported off-label uses

• Treatment of heavily calcified arterial lesions in vascular segments or clinical situations not included in the applicable device labeling.
• Use as an adjunct in complex peripheral interventions where plaque modification is intended to reduce the need for high-pressure ballooning or stenting.

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 a guidewire-compatible catheter and a diamond-coated orbital crown; available catheter and crown sizes depend on the specific model and vascular territory.
• It requires appropriate fluoroscopic imaging, compatible guidewire and sheath or guide-catheter access, and continuous saline infusion during operation according to the instructions for use.
• Device selection depends on vessel diameter, lesion length, calcium distribution, access anatomy and whether the coronary or peripheral system is being used.
• It is not generally considered MRI-safe while any component remains in the patient; MRI eligibility should be confirmed from the exact model's labeling after removal.
• Potential complications include dissection, perforation, embolization, thrombosis, spasm, bleeding, access-site complications and distal ischemia. Contraindications and warnings in the current instructions for use must be reviewed before treatment.