Diamondback 360 Peripheral Orbital Atherectomy System Stealth 360 Peripheral Orbital Atherectomy System

FDA-Cleared Indications

• For use in peripheral arteries to treat occlusive disease by reducing or modifying plaque.
• Intended for use in patients who are acceptable candidates for percutaneous peripheral vascular intervention.
• The device is designed to treat peripheral arterial lesions, including calcified lesions, before or during endovascular revascularization.

Clinical Applications

• Plaque modification in calcified peripheral arterial disease before balloon angioplasty.
• Treatment of stenotic or occlusive lesions in lower-extremity peripheral arteries.
• Preparation of heavily calcified lesions to improve balloon expansion or facilitate stent delivery.
• Endovascular treatment of peripheral arterial disease in patients with symptomatic limb ischemia, when percutaneous intervention is appropriate.

Reported off-label uses

• Use in selected heavily calcified iliofemoral arteries to facilitate large-bore access for procedures such as transcatheter aortic valve replacement may be described in clinical practice, but this application should be distinguished from the device's specific FDA-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 requires an appropriate guidewire, sheath or guiding catheter, and compatible lesion and vessel dimensions; exact compatibility depends on the specific catheter and console configuration.
• Orbital atherectomy is performed under fluoroscopic imaging, usually through femoral or radial access depending on the treated vascular territory and operator approach.
• The device is generally used with short, controlled treatment passes and blood-flow or saline requirements specified in the instructions for use; improper technique can increase the risk of embolization, dissection, perforation, thrombosis, or vessel spasm.
• It is not a stand-alone treatment for every peripheral lesion. Balloon angioplasty, stenting, drug-coated technology, surgical bypass, or medical therapy may also be appropriate.
• MRI safety depends on the specific component and whether it remains in the patient. The system should not be considered MRI safe without checking the current manufacturer labeling for the exact model and retained components.