Scimed Angiographic Kits

FDA-Cleared Indications

• Use in angiographic procedures to visualize blood vessels.
• Use with percutaneous catheter techniques for vascular imaging under fluoroscopic or radiographic guidance.

Clinical Applications

• Diagnostic angiography of peripheral blood vessels.
• Coronary angiography to visualize the coronary arteries.
• Cerebral angiography to visualize vessels supplying the brain.
• Vascular imaging during image-guided evaluation of suspected stenosis, occlusion, aneurysm, or other vascular abnormality.

Reported off-label uses

• Catheter and guidewire components of angiographic kits may be used in selected image-guided vascular interventions beyond diagnostic angiography, depending on the specific component labeling and institutional practice.

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

• Select the catheter shape, diameter, length, and guidewire characteristics for the access site and vascular territory being examined.
• Confirm compatibility among the catheter, guidewire, contrast injector, contrast agent, and imaging equipment before use.
• Use sterile technique and careful fluoroscopic guidance during vascular access, catheter advancement, and contrast injection.
• MRI safety is component-specific; do not assume the kit is MRI safe or MRI conditional without reviewing the labeling for each component.
• Consider standard angiography risks and contraindications, including vascular injury, bleeding, infection, thromboembolism, contrast reaction, and contrast-associated kidney injury.