Excelsior Xt-27 Microcatheter
Stryker Neurovascular
FDA Clearance Information
The Excelsior XT-27 microcatheter was cleared by the FDA via the 510(k) pathway on April 20, 2012. It is manufactured by Stryker Neurovascular and classified as a Class 2 device under product code DQY.
What It Is
FDA-Cleared Indications
- Used for the selective placement of diagnostic, therapeutic, or embolic materials in the peripheral and neurovascular vasculature.
- Intended for use with compatible guidewires and other interventional devices during catheter-based vascular procedures.
- FDA-cleared as a Class II percutaneous catheter under product code DQY.
Clinical Applications
- Selective catheter placement in cerebral and other peripheral blood vessels.
- Delivery of compatible embolic or therapeutic materials during catheter-based vascular treatment.
- Access and device delivery during neurovascular procedures requiring selective vessel navigation.
Reported off-label uses
- Use in stent-assisted or jailing techniques for intracranial aneurysm treatment.
- Use as an intermediate or aspiration microcatheter during suction thrombectomy for acute distal vessel occlusion.
- Use for delivery or support during other complex endovascular neurovascular procedures not specifically described in the general FDA product-code 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.
Evidence Summary
Reported Outcomes
Safety Profile
Evidence Limitations
Practical Considerations
- The catheter must be used with compatible guidewires, guide catheters, contrast media, and interventional devices; compatibility should be confirmed in the current instructions for use.
- It is navigated under fluoroscopic or other appropriate imaging guidance by clinicians trained in endovascular procedures.
- Device dimensions, distal tip configuration, and inner and outer diameters determine which guidewires and treatment devices can be used.
- MRI safety depends on the specific device configuration and labeling. The current manufacturer instructions should be checked before MRI; do not assume the catheter is safe while it is in place.
- Risks include vessel injury, dissection, perforation, thromboembolism, bleeding, infection, vasospasm, catheter entrapment, and allergic or kidney-related reactions to contrast.
Frequently Asked Questions
What are the clinical indications for Excelsior XT-27 microcatheter?
The Excelsior XT-27 is indicated for use in neurovascular procedures, including stent delivery in aneurysm treatment and suction thrombectomy for acute distal occlusions.
What outcomes have been reported in clinical studies?
Studies report successful stent delivery in aneurysm treatment and effective recanalization in thrombectomy procedures, highlighting the device's efficacy in complex neurovascular interventions.
What complications have been reported?
Reported complications include potential interference between microcatheters during certain procedures, though no significant adverse events were noted in the studies reviewed.