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Axs Catalyst Distal Access Catheter 058x115cm Axs Catalyst Distal Access Catheter 058x132cm Axs Catalyst Distal Access Catheter 060x132cm
Summary: The AXS Catalyst Distal Access Catheter by Stryker is designed for neurovascular interventions, particularly in stroke management. Key evidence highlights its use in medium distal vessel occlusion and aneurysm treatment.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K151667 ↗
Decision Date ?
November 13, 2015
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The AXS Catalyst Distal Access Catheter was cleared via the FDA 510(k) pathway on November 13, 2015. It is manufactured by Stryker and classified as a Class 2 device under product code DQY.
What It Is
The AXS Catalyst Distal Access Catheter is a neurovascular device used to provide distal access in the cerebral vasculature. It is intended for use in endovascular procedures, offering enhanced trackability and stability.
FDA-Cleared Indications
- For use in the peripheral and neurovasculature to introduce interventional devices.
- Intended to provide access to the peripheral and neurovasculature during diagnostic and therapeutic procedures.
- The device is cleared as a percutaneous catheter under FDA product code DQY.
Clinical Applications
- Providing distal catheter access and support during cerebral angiography and other neuroendovascular procedures.
- Introducing compatible interventional devices into the cerebral vasculature.
- Supporting endovascular treatment procedures when catheter stability and distal access are required.
Reported off-label uses
- Use as an aspiration or intermediate catheter for selected intracranial large- or medium-vessel occlusion procedures, depending on the specific model, anatomy and local protocol.
- Use to support delivery of devices during selected intracranial aneurysm interventions.
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
The literature includes five studies, comprising RCTs, prospective, and retrospective analyses, conducted between 2019 and 2025. These studies explore the catheter's application in stroke and aneurysm treatments.
Reported Outcomes
Published studies report the AXS Catalyst Distal Access Catheter's efficacy in improving procedural success in medium distal vessel occlusion strokes and aneurysm flow diversion. The catheter's design enhances distal access and stability, contributing to favorable clinical outcomes.
Safety Profile
Reported complications include potential risks associated with endovascular procedures, such as vessel injury or device-related complications. However, specific safety data from the provided evidence is limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of comprehensive safety data. Further research is needed to establish long-term outcomes and safety profiles in diverse patient populations.
Practical Considerations
- Available configurations listed in this record include 0.058-inch inner diameter with 115 cm or 132 cm length, and 0.060-inch inner diameter with 132 cm length.
- The catheter must be matched with compatible guidewires, microcatheters, aspiration tubing and other interventional devices according to the current manufacturer instructions for use.
- It is advanced percutaneously under fluoroscopic guidance, commonly through femoral or radial arterial access depending on the procedure and operator preference.
- Users should review the current labeling for vessel-size limits, compatibility, pressure or aspiration limits, contraindications and MRI conditions before use.
- It is a single-use catheter and should not be resterilized or reused.
Frequently Asked Questions
What are the clinical indications for AXS Catalyst Distal Access Catheter?
The catheter is indicated for use in neurovascular interventions, particularly in medium distal vessel occlusion strokes and intracranial aneurysm treatments.
What outcomes have been reported in clinical studies?
Studies report improved procedural success and enhanced stability during neurovascular interventions, particularly in stroke and aneurysm cases.
What complications have been reported?
Reported complications include potential vessel injury and device-related issues, though specific safety data is limited in the current evidence.
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.