đź“Š Evidence-Based Reference
axs catalyst distal access catheter 068 x 115cm axs catalyst distal access catheter 068 x 125cm axs catalyst distal access catheter 068 x 132cm
Stryker
Summary: The AXS Catalyst Distal Access Catheter by Stryker is designed for endovascular procedures, particularly in neurovascular interventions. Key evidence highlights its use in stroke and aneurysm treatments.
FDA Clearance Information
Pathway
510K
Number
K183463 ↗
Decision Date
March 13, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The AXS Catalyst Distal Access Catheter received FDA clearance via the 510(k) pathway on March 13, 2019. Manufactured by Stryker, it is classified as a Class 2 device.
What It Is
The AXS Catalyst Distal Access Catheter is a neurovascular device used to provide distal access during endovascular procedures. It is designed to enhance trackability and stability, facilitating interventions such as thrombectomy and aneurysm flow diversion.
Clinical Applications
Commonly used in the treatment of medium distal vessel occlusion strokes and intracranial aneurysms, the catheter aids in providing stable access for complex neurointerventions.
Evidence Summary
The literature includes five studies, comprising RCTs, prospective, and retrospective analyses, published between 2019 and 2025. These studies explore the catheter's application in stroke and aneurysm treatments.
Reported Outcomes
Published studies report the catheter's efficacy in improving procedural success in neurovascular interventions, particularly in stroke and aneurysm cases. The device is noted for its enhanced trackability and stability, contributing to favorable clinical outcomes.
Safety Profile
Reported complications include potential risks associated with endovascular procedures, such as vessel injury or thromboembolic events. However, specific safety data from the studies are limited.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale RCTs. Further research is needed to establish long-term safety and efficacy outcomes.
Frequently Asked Questions
What are the clinical indications for AXS Catalyst Distal Access Catheter?
The catheter is indicated for use in neurovascular interventions, including the treatment of medium distal vessel occlusion strokes and intracranial aneurysms.
What outcomes have been reported in clinical studies?
Studies report improved procedural success and favorable clinical outcomes in stroke and aneurysm treatments, highlighting the catheter's trackability and stability.
What complications have been reported?
Reported complications include risks typical of endovascular procedures, such as vessel injury or thromboembolic events, though specific data are limited.
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.