📊 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
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 ?
510(k)
Number ?
K183463 ↗
Decision Date ?
March 13, 2019
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- For introducing interventional devices into the peripheral, coronary, and neurovascular vasculature.
- For use in patients who require percutaneous endovascular access to blood vessels.
Clinical Applications
- Providing distal catheter access during neurovascular endovascular procedures.
- Supporting delivery and positioning of compatible interventional devices in the neurovascular circulation.
- Providing catheter access during selected peripheral or coronary endovascular procedures, when used consistently with the cleared labeling and device compatibility requirements.
Reported off-label uses
- Use as an intermediate or distal-access catheter during selected thrombectomy procedures for acute ischemic stroke.
- Use as an access or support catheter during treatment of intracranial aneurysms, including procedures involving flow-diversion devices.
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, 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.
Practical Considerations
- The listed configuration has a 0.068-inch inner diameter and is available in 115 cm, 125 cm, and 132 cm lengths; the appropriate length depends on the access site, vascular anatomy, and procedure.
- Use requires a compatible guide catheter or sheath, guidewire, and interventional device system according to the manufacturer's instructions for use.
- The catheter is intended for fluoroscopic or other appropriate image-guided navigation and should be advanced carefully to reduce the risk of vessel injury, dissection, perforation, or vasospasm.
- MRI safety depends on the specific device configuration and labeling; the catheter should not be assumed to be MR safe or MR conditional without checking the current manufacturer's instructions.
- Potential contraindications and warnings include unsuitable vascular anatomy, severe vessel disease, active infection at the access site, bleeding risk, and inability to receive the required anticoagulation or contrast, as clinically applicable.
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.