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axs offset delivery assist catheter
Stryker Neurovascular
Summary: The AXS Offset Delivery Assist Catheter is designed to aid in mechanical thrombectomy by reducing the ledge effect during device navigation. Key evidence suggests improved navigation in tortuous vascular pathways.
FDA Clearance Information
Pathway
510K
Number
K163259 ↗
Decision Date
July 28, 2017
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The AXS Offset Delivery Assist Catheter was cleared by the FDA through the 510(k) pathway on July 28, 2017. It is manufactured by Stryker Neurovascular and classified as a Class 2 device.
What It Is
The AXS Offset Delivery Assist Catheter is a medical device designed to assist in the delivery of large-bore aspiration catheters during mechanical thrombectomy procedures. It features a flexible, spindle-shaped shaft intended to reduce the ledge effect, facilitating smoother navigation through tortuous vascular pathways.
Clinical Applications
This device is commonly used in mechanical thrombectomy procedures for acute ischemic stroke patients. It aids in the navigation and delivery of large-bore catheters for intracranial thromboaspiration, particularly in challenging vascular anatomies.
Evidence Summary
The available literature includes two peer-reviewed studies published between 2020 and 2024. These studies encompass various methodologies, including retrospective and prospective analyses, focusing on the device's efficacy and safety in clinical settings.
Reported Outcomes
Published studies report that the AXS Offset Delivery Assist Catheter improves catheter navigation in mechanical thrombectomy procedures. The device's design helps mitigate the ledge effect, potentially enhancing procedural success in complex vascular anatomies.
Safety Profile
Reported complications include no specific adverse events directly attributed to the device in the provided studies. However, general procedural risks associated with mechanical thrombectomy remain applicable.
Evidence Limitations
The evidence is limited by the small number of studies and the lack of large-scale randomized controlled trials. Further research is needed to establish long-term outcomes and comparative effectiveness against other devices.
Frequently Asked Questions
What are the clinical indications for AXS Offset Delivery Assist Catheter?
The device is indicated for use in mechanical thrombectomy procedures to assist in the delivery of large-bore catheters for intracranial thromboaspiration.
What outcomes have been reported in clinical studies?
Studies report improved catheter navigation and reduced ledge effect during mechanical thrombectomy, enhancing procedural success.
What complications have been reported?
No specific complications directly attributed to the device were reported in the studies, though general procedural risks remain.
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.