Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series

FDA-Cleared Indications

• Treatment of peripheral arterial disease in the peripheral vasculature.
• Modification of stenotic lesions, including calcified lesions, before or during revascularization.
• Use in peripheral arteries that can accommodate the device's delivery catheter and guidewire system.

Clinical Applications

• Plaque modification before balloon angioplasty in calcified peripheral arterial lesions.
• Treatment preparation for lower-extremity peripheral artery revascularization.
• Facilitation of vessel expansion when calcified plaque limits balloon treatment.
• Treatment of stenotic lesions in peripheral arteries as part of an endovascular revascularization procedure.

Reported off-label uses

• Use in selected vascular access lesions to improve access for another cardiovascular procedure may be reported in clinical practice, but this application should be evaluated against the device labeling and institutional policy.

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 compatible guidewire and catheter access system; the available catheter and crown configuration must match the target vessel and lesion.
• Treatment requires fluoroscopic imaging, controlled device advancement and withdrawal, and appropriate saline or lubricant management according to the instructions for use.
• Heavily calcified, tortuous or small vessels may increase the risk of dissection, perforation, embolization, thrombosis or slow flow.
• The device is not a permanent implant. MRI considerations generally relate to any other implanted device or treated vessel material; follow the current manufacturer labeling and institutional MRI screening policy.
• Contraindications and warnings include inability to cross the lesion safely, unsuitable vessel size or anatomy, untreated significant thrombus, and conditions in which endovascular revascularization is not appropriate.