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Excelsior Xt-17 Microcatheter Excelsior Xt-17 Flex Microcatheter Excelsior Xt-17 Pre-Shaped Microcatheter Excelsior Xt-17 Flex Pre-Shaped Microcatheter
Stryker Neurovascular
Summary: The Excelsior XT-17 Microcatheter is a flexible catheter used in neurovascular procedures, particularly for intracranial aneurysm coiling. It is primarily utilized by interventional neuroradiologists and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K142565 ↗
Decision Date ?
November 14, 2014
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Excelsior XT-17 Microcatheter received FDA clearance through the 510(k) pathway on November 14, 2014. It is manufactured by Stryker Neurovascular and classified as a Class 2 device under product code DQY.
What It Is
The Excelsior XT-17 Microcatheter is a highly flexible and shapable catheter designed for use in neurovascular interventions. It allows for precise navigation through the complex and tortuous anatomy of cerebral vessels. The device is available in various configurations, including pre-shaped options, to accommodate different procedural needs.
FDA-Cleared Indications
- Intended for introduction into the peripheral and neuro vasculature.
- Used to deliver diagnostic, therapeutic, or embolic materials when access to the target vessel is required.
- Used with compatible guidewires and accessories during catheter-based vascular procedures.
Clinical Applications
- Catheter-based access to selected peripheral blood vessels.
- Catheter-based access to selected neurovascular vessels.
- Delivery of compatible interventional or embolic materials when permitted by the device labeling and procedural system.
- Use during image-guided vascular procedures requiring a flexible, navigable microcatheter.
Reported off-label uses
- Delivery of coils or other embolic materials for intracranial aneurysm embolization when the specific configuration and procedural use are not included in the device labeling.
- Selective catheterization for other complex neurovascular embolization procedures described in clinical practice.
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 product family includes standard, Flex, pre-shaped, and Flex pre-shaped configurations; the selected configuration should match the target anatomy and procedure.
- The catheter is used with compatible guidewires and interventional materials. Compatibility, working length, inner diameter, and outer diameter should be confirmed before use.
- Navigation should be performed under appropriate fluoroscopic or other approved imaging guidance, using careful wire and catheter technique to reduce the risk of vessel injury.
- MRI compatibility depends on the exact product configuration and labeling; the device should not be assumed to be MRI safe without checking the current manufacturer instructions for use.
- Contraindications, warnings, and restrictions are specified in the current manufacturer labeling. Potential complications of vascular catheterization include bleeding, infection, vessel injury, thrombosis, embolization, and neurologic complications.
Related Literature
The linked study explored a novel method of shaping the Excelsior XT-17 Microcatheter for coiling aneurysms in the vertebrobasilar artery. The study highlighted the challenges of navigating the tortuous anatomy of these vessels and demonstrated preliminary success using patient-specific shaping techniques. However, the study was limited by its small sample size and preliminary nature.
Frequently Asked Questions
What is the Excelsior XT-17 Microcatheter used for?
It is used for neurovascular interventions, particularly in intracranial aneurysm coiling procedures.
What specialties typically use this device?
Interventional neuroradiologists and neurosurgeons commonly use this device.
What are the FDA-cleared indications?
The device is indicated for use in neurovascular procedures involving venous stents, particularly in the treatment of intracranial aneurysms.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.