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axera 2 access system
Arstasis
Summary: The Axera 2 Access System is a vascular closure device used in neurovascular procedures. It is FDA 510k cleared and has been evaluated in two studies, highlighting its application in cerebral angiography.
FDA Clearance Information
Pathway
510K
Number
K123618 ↗
Decision Date
March 24, 2013
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Axera 2 Access System by Arstasis received FDA clearance through the 510k pathway on March 24, 2013. It is classified as a Class 2 device under product code DYB.
What It Is
The Axera 2 Access System is a vascular closure device designed to facilitate arterial access and closure in neurovascular procedures. It aims to reduce the need for manual compression and prolonged bed rest post-procedure.
Clinical Applications
Commonly used in cerebral angiography, the Axera 2 Access System provides an alternative to traditional methods of vascular closure. It is particularly relevant in procedures requiring rapid hemostasis and patient mobilization.
Evidence Summary
The available literature includes two studies: one published in 2017 and a clinical trial with an unknown status. These studies provide initial insights into the device's application and outcomes.
Reported Outcomes
Published studies report that the Axera 2 Access System is effective in achieving arterial closure in neurovascular procedures. However, specific efficacy metrics are not detailed in the provided evidence.
Safety Profile
Reported complications include 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 to two studies, with one lacking detailed outcomes and safety data. Further research is needed to establish comprehensive efficacy and safety profiles.
Frequently Asked Questions
What are the clinical indications for Axera 2 Access System?
The Axera 2 Access System is indicated for use in neurovascular procedures, particularly cerebral angiography, to facilitate arterial access and closure.
What outcomes have been reported in clinical studies?
Clinical studies report effective arterial closure, but specific efficacy outcomes are not detailed in the available evidence.
What complications have been reported?
Safety data indicate potential complications such as arterial dissection, groin hematoma, and device failure.
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.