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axs vecta aspiration catheter
Stryker Neurovascular
Summary: The AXS Vecta Aspiration Catheter by Stryker Neurovascular is a device used in mechanical thrombectomy for stroke treatment. It is FDA-cleared and supported by studies highlighting its use in direct aspiration thrombectomy.
FDA Clearance Information
Pathway
510K
Number
K190833 ↗
Decision Date
December 15, 2019
Product Code
DQY
Device Class
Class 2
Evidence
0 studies
The AXS Vecta Aspiration Catheter was cleared through the FDA 510(k) pathway on December 15, 2019. It is manufactured by Stryker Neurovascular and classified as a Class 2 device.
What It Is
The AXS Vecta Aspiration Catheter is designed for use in mechanical thrombectomy procedures, specifically for the removal of thrombi in patients experiencing ischemic stroke. It features a 0.071-inch diameter, facilitating direct aspiration of clots.
Clinical Applications
This device is commonly used in acute ischemic stroke cases where rapid clot removal is critical. It is particularly applicable in scenarios requiring direct aspiration techniques.
Evidence Summary
The literature includes three studies, with one published in 2020. These studies encompass various methodologies, including RCTs and case series, focusing on the catheter's efficacy in thrombectomy procedures.
Reported Outcomes
Published studies report that the AXS Vecta Aspiration Catheter is effective in facilitating direct aspiration thrombectomy, with initial experiences indicating successful clot removal. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include typical risks associated with mechanical thrombectomy, such as vessel injury or hemorrhage. The provided evidence does not specify the incidence rates of these complications.
Evidence Limitations
The evidence base is limited by the small number of studies and lack of detailed outcome metrics. Further research is needed to establish comprehensive safety and efficacy profiles.
Frequently Asked Questions
What are the clinical indications for AXS Vecta Aspiration Catheter?
The device is indicated for use in mechanical thrombectomy procedures in patients with acute ischemic stroke.
What outcomes have been reported in clinical studies?
Studies report successful clot removal using direct aspiration techniques, though specific efficacy metrics are not detailed.
What complications have been reported?
Reported complications include vessel injury and hemorrhage, typical of mechanical thrombectomy procedures.
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.