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Axs Vecta Aspiration Catheter
Stryker Neurovascular
Product: Axs Vecta 71 — all models and sizes
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 ?
510(k)
Number ?
K190833 ↗
Decision Date ?
December 15, 2019
Product Code ?
DQY Catheter, Percutaneous
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.
FDA-Cleared Indications
- Intended for the removal of thrombi and emboli from the peripheral and neurovasculature.
- Used with compatible aspiration or thrombectomy systems during percutaneous endovascular procedures.
- The device is a Class II percutaneous catheter cleared through the FDA 510(k) pathway.
Clinical Applications
- Aspiration thrombectomy for removal of blood clots from selected peripheral vessels.
- Endovascular clot removal in the neurovasculature when used according to the device labeling and with compatible equipment.
- Catheter-based treatment of acute thrombotic or embolic vessel occlusion selected by the treating physician.
Reported off-label uses
- Use in venous thrombectomy procedures, such as treatment of selected deep vein thrombosis, may be reported in clinical practice but should not be assumed to be covered by the device labeling.
- Use in other vascular beds or with techniques not specified in the instructions for use is off-label and depends on physician judgment, institutional policy, and applicable regulations.
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 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.
Practical Considerations
- The AXS Vecta platform includes catheter sizes intended for aspiration access; the commonly referenced Vecta 71 has an approximately 0.071-inch inner diameter. Exact sizes and compatibility should be confirmed in the current instructions for use.
- The catheter is advanced over a guidewire or through a compatible access system under fluoroscopic imaging by trained endovascular specialists.
- Compatibility with the guidewire, aspiration pump or tubing, hemostatic valve, and other thrombectomy components must be checked before use.
- MRI safety depends on the specific device configuration and whether the catheter remains in the patient; consult the current manufacturer labeling before MRI.
- Risks include vessel injury, perforation, dissection, bleeding, embolization, infection, contrast reaction, and complications related to access-site anesthesia or sedation.
Procedures that use this device
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.