Plato 17 Microcatheter

FDA-Cleared Indications

• For percutaneous introduction into the vascular system during endovascular procedures.
• For selective access to blood vessels to deliver therapeutic agents or compatible interventional devices.
• For use when treatment requires catheter navigation through small or difficult-to-access vessels.

Clinical Applications

• Selective vascular access during endovascular treatment.
• Delivery of compatible therapeutic agents or embolic materials to a targeted vascular territory.
• Delivery or positioning of compatible interventional devices during vascular procedures.
• Access to small or tortuous vessels when standard catheter systems may not provide sufficient selectivity.

Reported off-label uses

• Delivery of embolic agents for selected tumor or arteriovenous malformation embolization procedures when the specific use is not included in the device labeling.
• Selective catheterization in neurovascular procedures when the device, anatomy, and intended use are not covered by its 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 operator should confirm the available catheter configurations, vessel compatibility, guidewire requirements, and compatibility with the intended therapeutic agent or device before use.
• The microcatheter should be advanced under appropriate fluoroscopic or other validated imaging guidance by clinicians trained in endovascular catheterization.
• Use requires careful handling in small or tortuous vessels to reduce the risk of vessel injury, dissection, perforation, spasm, thrombosis, or catheter damage.
• MRI safety depends on the specific product configuration and labeling; users should verify the current manufacturer instructions before an MRI examination.
• Contraindications, warnings, and compatibility limits should be reviewed in the current instructions for use. The device is not a permanent implant and is removed after the procedure unless the labeling specifies otherwise.