Trevo Trak 21 Microcatheter

FDA-Cleared Indications

• A catheter intended for percutaneous introduction into the neurovasculature.
• Used to facilitate the delivery of diagnostic, therapeutic, and other compatible interventional devices into the neurovasculature.
• Use is limited to the specific indications, anatomy, device combinations, and patient populations described in the current FDA-cleared labeling.

Clinical Applications

• Providing access to intracranial arteries during endovascular treatment of acute ischemic stroke.
• Delivering compatible thrombectomy or clot-retrieval devices to an intracranial occlusion.
• Delivering compatible neurovascular devices during selected aneurysm or other intracranial vascular procedures, when specified in the device labeling.
• Navigating through the neurovasculature under fluoroscopic guidance to position an interventional device.

Reported off-label uses

• Use as an access or delivery catheter for selected intracranial embolization procedures outside the device's specific cleared labeling.
• Delivery of embolic materials or devices in selected neurovascular applications not expressly included in the FDA-cleared indication.

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 catheter is a small-lumen neurovascular microcatheter; the treating physician must confirm compatibility with the guidewire, access catheter, thrombectomy device, embolic agent, and other equipment being used.
• It is advanced through a guide catheter or similar access system under fluoroscopic guidance, generally through femoral or radial arterial access.
• The physician should review the current instructions for use for vessel-size limits, usable length, guidewire requirements, pressure limits, and device-specific contraindications or warnings.
• MRI safety depends on the exact device configuration and whether the catheter remains in the patient; follow the current labeling and institutional MRI screening policy.
• Potential complications are associated with catheterization and neurovascular intervention, including vessel injury, dissection, perforation, vasospasm, thromboembolism, bleeding, infection, and stroke.