Diamondback 360 Degree Orbital Atherectomy System

FDA-Cleared Indications

• Treatment of de novo or restenotic lesions in peripheral arteries that are suitable for percutaneous transluminal angioplasty.
• Treatment of severely calcified coronary artery lesions in patients undergoing percutaneous coronary intervention, when covered by the specific system labeling.
• Modification of calcified plaque to facilitate balloon angioplasty or other endovascular treatment.

Clinical Applications

• Atherectomy or plaque modification in selected calcified peripheral arterial lesions.
• Preparation of calcified peripheral lesions before balloon angioplasty.
• Plaque modification in selected severely calcified coronary lesions during percutaneous coronary intervention, when included in the applicable device labeling.
• Treatment planning for symptomatic peripheral arterial disease when calcification may limit balloon expansion.

Reported off-label uses

• Use in selected below-the-knee or other small-vessel lesions beyond the specific cleared labeling.
• Use in heavily calcified lesions or vascular segments not specifically covered by the applicable catheter indication.

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 available with different catheter and crown configurations; vessel-size compatibility, guidewire requirements, and treatment limits must be checked in the current instructions for use.
• It is advanced over a guidewire under fluoroscopic imaging, usually through femoral or radial access depending on the vascular territory and operator approach.
• Treatment commonly uses short activation runs with saline or other required flushing and controlled advancement; prolonged activation or excessive force can increase the risk of vessel injury, embolization, heat generation, or device malfunction.
• The device is not a substitute for treatment of every arterial blockage. Balloon angioplasty, stenting, drug therapy, bypass surgery, or other atherectomy systems may be appropriate alternatives.
• MRI safety depends on the specific catheter and whether it remains in the patient; the current device labeling should be reviewed before MRI. The system is generally used as a temporary procedural device and is not implanted for long-term therapy.