đź“Š Evidence-Based Reference
axs catalyst distal access catheter 058x115cm axs catalyst distal access catheter 058x132cm axs catalyst distal access catheter 060x132cm
Stryker
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
510K
Number
K151667 ↗
Decision Date
November 13, 2015
Product Code
DQY
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.
Clinical Applications
Commonly used in the treatment of medium distal vessel occlusion strokes and intracranial aneurysms, the catheter facilitates endovascular access and support during complex neurointerventions.
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.
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.