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Axera 2 Access System
Arstasis
Summary: The Axera 2 Access System by Arstasis is a vascular access and closure device primarily used in neurovascular procedures. Key evidence highlights its initial use and safety profile.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K140201 ↗
Decision Date ?
March 28, 2014
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Axera 2 Access System was cleared through the FDA 510(k) pathway on March 28, 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 access and 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.
FDA-Cleared Indications
- Used to facilitate percutaneous access to the femoral artery.
- Used to assist arterial closure and hemostasis after catheter-based procedures.
- Cleared as a Class II device through the FDA 510(k) pathway under product code DYB.
Clinical Applications
- Femoral arterial access for cerebral angiography.
- Femoral arterial access for neurointerventional procedures.
- Arterial closure after diagnostic or interventional catheter procedures.
- An alternative to prolonged manual compression after femoral arterial access.
Evidence Summary
The available literature includes two studies: an initial experience report and a randomized controlled trial. The studies focus on the device's application in neurovascular procedures, with publication years ranging from 2017 to unknown.
Reported Outcomes
Published studies report initial experiences with the Axera 2 Access System in neurovascular procedures, highlighting its potential as an alternative to manual compression. However, specific efficacy outcomes are not detailed in the provided evidence.
Safety Profile
Reported complications include arterial dissection, groin hematoma, and device failure, as noted in the initial experience study. These risks are associated with the use of vascular closure devices in general.
Evidence Limitations
The evidence is limited by the small number of studies and lack of detailed outcome data. Further research is needed to establish comprehensive efficacy and safety profiles, as well as long-term outcomes.
Practical Considerations
- The system is intended for femoral arterial access; the treating clinician should confirm that the patient's anatomy and access site are appropriate.
- Device size and compatibility depend on the access needle, sheath, catheter system and procedure requirements; clinicians should follow the current manufacturer instructions for use.
- Potential complications of femoral access and closure include bleeding, hematoma, pseudoaneurysm, arterial thrombosis, infection and vessel injury.
- MRI safety should be confirmed from the current product labeling and device components before MRI. Do not assume MRI compatibility based only on the device name.
- Contraindications and precautions include unsuitable femoral anatomy, significant peripheral arterial disease, infection at the access site and inability to follow post-procedure activity restrictions.
Procedures that use this device
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 for arterial access and closure in cerebral angiography.
What outcomes have been reported in clinical studies?
The initial experience study highlights the device's potential as an alternative to manual compression, but specific efficacy outcomes are not detailed.
What complications have been reported?
Safety data from the evidence indicates 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.