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axera 2 access system
Arstasis
Summary: The Axera 2 Access System by Arstasis is a device for arterial access and closure, primarily used in neurovascular procedures. Key evidence includes initial experiences and a randomized controlled trial evaluating its efficacy and safety.
FDA Clearance Information
Pathway
510K
Number
K140871 ↗
Decision Date
June 6, 2014
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The Axera 2 Access System was cleared by the FDA via the 510(k) pathway on June 6, 2014. 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 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 by providing a reliable closure mechanism.
Clinical Applications
Commonly used in cerebral angiography and other neurovascular procedures, the Axera 2 Access System provides an alternative to traditional manual compression methods, potentially improving patient comfort and reducing recovery time.
Evidence Summary
The available literature includes an initial experience study and a randomized controlled trial, focusing on the device's application in neurovascular procedures. These studies provide insights into the device's performance and safety profile.
Reported Outcomes
Published studies report that the Axera 2 Access System is effective in achieving arterial closure in neurovascular procedures. Initial experiences suggest it may offer benefits over traditional methods, though comprehensive outcome data is limited.
Safety Profile
Reported complications include risks such as arterial dissection, groin hematoma, and device failure. These are consistent with known risks associated with vascular closure devices.
Evidence Limitations
The evidence is limited to initial experiences and a trial with unspecified outcomes, highlighting the need for further research to establish comprehensive efficacy and safety profiles. Larger studies with detailed outcomes are necessary to confirm these findings.
Frequently Asked Questions
What are the clinical indications for Axera 2 Access System?
The Axera 2 Access System is indicated for arterial access and closure in neurovascular procedures, such as cerebral angiography.
What outcomes have been reported in clinical studies?
Initial studies suggest effective arterial closure, though detailed outcome data is limited.
What complications have been reported?
Reported complications include 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.