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axera 2 access system
Arstasis
Summary: The Axera 2 Access System is a vascular access device used primarily in neurovascular procedures. It offers an alternative to manual compression for arterial closure. Key evidence highlights its initial use in cerebral angiography.
FDA Clearance Information
Pathway
510K
Number
K132263 ↗
Decision Date
August 19, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Axera 2 Access System was cleared by the FDA via the 510k pathway on August 19, 2013. It is manufactured by Arstasis and classified as a Class 2 device under product code DYB.
What It Is
The Axera 2 Access System is a device designed for arterial access and closure, primarily used in neurovascular procedures. It aims to reduce the need for manual compression and prolonged bed rest by facilitating vascular closure.
Clinical Applications
Commonly used in cerebral angiography, the Axera 2 Access System is employed in scenarios requiring efficient vascular access and closure. It is particularly relevant in neurovascular interventions where rapid hemostasis is desired.
Evidence Summary
The available literature includes two studies: one published in 2017 and another with an unknown date. These studies explore the initial experiences and outcomes associated with the Axera 2 Access System in clinical settings.
Reported Outcomes
Published studies report initial experiences with the Axera 2 Access System in neurovascular procedures, highlighting its role in facilitating arterial closure. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include potential risks such as arterial dissection, groin hematoma, and device failure. These are common concerns associated with vascular closure devices.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles for the Axera 2 Access System.
Frequently Asked Questions
What are the clinical indications for Axera 2 Access System?
The Axera 2 Access System is indicated for use in procedures requiring arterial access and closure, such as cerebral angiography.
What outcomes have been reported in clinical studies?
Initial experiences suggest the device facilitates arterial closure, but specific outcomes are not detailed in the provided studies.
What complications have been reported?
Safety data indicate risks of arterial dissection, groin hematoma, and device failure associated with the Axera 2 Access System.
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.