Tigertriever 13 Ultra Revascularization Device
FDA Clearance Information
FDA-Cleared Indications
- For restoring blood flow by removing thrombus from the neurovasculature in patients with acute ischemic stroke.
- For use in appropriately selected patients with a persistent, disabling neurological deficit caused by large-vessel occlusion.
- For use by trained physicians with compatible endovascular access and imaging equipment.
Clinical Applications
- Mechanical thrombectomy for acute ischemic stroke caused by an intracranial large-vessel occlusion.
- Endovascular clot retrieval in the internal carotid artery or proximal middle cerebral artery, when the patient meets the device labeling and institutional stroke-treatment criteria.
- Use through a compatible microcatheter during catheter-based stroke intervention.
- Clot removal after diagnostic cerebral angiography confirms a treatable arterial occlusion.
Reported off-label uses
- Use for selected distal or medium-vessel occlusions outside the labeled vessel and size range.
- Use for selected posterior-circulation occlusions, including basilar artery thrombectomy, when supported by physician judgment and available evidence.
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 device is designed for neurovascular clot retrieval and must be used with compatible access catheters, microcatheters, guidewires and aspiration equipment specified in the instructions for use.
- Device size and deployment location must match the target vessel and thrombus; the 13 Ultra model is intended for smaller neurovascular anatomy than larger thrombectomy devices.
- Use requires fluoroscopic and angiographic guidance, usually through femoral or radial arterial access, with conscious sedation or general anesthesia depending on the patient and treatment plan.
- Important risks include vessel perforation or dissection, intracranial hemorrhage, embolization to a new territory, vasospasm, stroke progression, infection and complications at the arterial access site.
- MRI safety and scan conditions depend on the device's current instructions for use and whether it remains implanted; a retrievable device is normally removed during the procedure and is not intended as a permanent implant.
Procedures that use this device
Frequently Asked Questions
What is the Tigertriever 13 Ultra used for?
It is used during mechanical thrombectomy to remove a blood clot from a brain artery in selected patients with acute ischemic stroke.
Is the Tigertriever 13 Ultra MRI safe?
The device is intended to be retrieved during the procedure rather than left permanently implanted. Follow the current manufacturer instructions for MRI conditions, especially if any device component remains in the body.
What size vessels can the Tigertriever 13 Ultra treat?
It is designed for smaller neurovascular anatomy within the vessel-size and access limits in its FDA labeling and instructions for use. The treating neurointerventional physician selects the device size after angiographic evaluation.
How long does the Tigertriever 13 Ultra last?
It is a temporary device used during one thrombectomy procedure and is removed after clot retrieval. It is not intended to remain implanted as a permanent stent.
How much does the Tigertriever 13 Ultra cost?
The device price is generally part of the hospital's overall stroke-thrombectomy and procedure charges. Patient out-of-pocket cost depends on insurance coverage, hospital contracts, emergency care benefits and other treatment costs.