Tracker Excel -14 Pre-Shaped Microcatheter

FDA-Cleared Indications

• For percutaneous intravascular access and delivery of compatible therapeutic agents or devices within the vascular system.
• For use with standard guidewires and fluoroscopic imaging during endovascular procedures.

Clinical Applications

• Selective catheterization of peripheral blood vessels for delivery of compatible agents or devices.
• Access to difficult-to-reach vascular anatomy during image-guided endovascular treatment.
• Delivery of embolic materials or other compatible therapeutic agents when specified by the treating physician and device labeling.

Reported off-label uses

• Selective delivery during neurovascular embolization procedures, depending on the specific model, anatomy, and current labeling.
• Delivery of investigational or non-labeled agents in specialized endovascular procedures.

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 pre-shaped tip is intended to help with selective navigation, but the appropriate shape, length, and diameter depend on the target vessel and anatomy.
• Use requires fluoroscopic guidance and compatible guidewires, connectors, and therapeutic agents or devices.
• The available size range and compatibility should be confirmed in the current manufacturer labeling before use.
• MRI safety is not established by the provided FDA record; consult the current device labeling before an MRI examination.
• As with other intravascular catheters, potential complications include vessel injury, bleeding, thrombosis, embolization, infection, and contrast-related reactions.