📊 Evidence-Based Reference
Axera Access System
Arstasis
Summary: The Axera Access System by Arstasis is a vascular access device cleared by the FDA for use in embolization procedures. Key evidence highlights its use in neurovascular angiography with noted safety and efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K113110 ↗
Decision Date ?
November 9, 2011
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Axera Access System was cleared via the FDA 510(k) pathway on November 9, 2011. Manufactured by Arstasis, it is classified as a Class 2 device under product code DYB.
What It Is
The Axera Access System is a vascular access device designed to facilitate arterial access and closure. It employs a dual arteriotomy mechanism to minimize trauma and improve hemostasis, primarily used in neurovascular and embolization procedures.
FDA-Cleared Indications
- Used to facilitate percutaneous access to the femoral artery for catheter-based vascular procedures.
- Used to assist closure and hemostasis at the femoral arterial access site after the procedure.
- FDA-cleared as a Class II device under product code DYB through the 510(k) pathway.
Clinical Applications
- Femoral arterial access for embolization procedures.
- Femoral access for neurovascular angiography and related catheter-based procedures.
- Arterial access and closure when an alternative to manual compression and prolonged bed rest is appropriate.
Evidence Summary
The literature includes four studies, comprising randomized controlled trials and observational studies, conducted between 2017 and 2018. These studies evaluate the safety and efficacy of the Axera Access System in clinical settings.
Reported Outcomes
Published studies report that the Axera Access System is effective in achieving vascular access with reduced procedural time and improved hemostasis. The device has been shown to facilitate successful arterial closure in neurovascular procedures.
Safety Profile
Reported complications include arterial dissection, groin hematoma, and device failure. These adverse events are consistent with those associated with other vascular closure devices.
Evidence Limitations
The evidence is limited by small sample sizes and a lack of long-term follow-up data. Further research is needed to confirm the device's efficacy and safety across diverse patient populations and clinical settings.
Practical Considerations
- The device is intended for arterial access through the femoral artery; appropriate vessel size, anatomy, and puncture location must be confirmed before use.
- Use requires fluoroscopic or other image-guided vascular access and standard sterile technique.
- Compatibility with the planned catheter, guidewire, and embolization equipment should be confirmed before the procedure.
- Patients with severe peripheral arterial disease, an unsuitable common femoral artery, infection at the access site, or significant coagulation abnormalities may not be appropriate candidates.
- MRI safety information should be confirmed in the current manufacturer labeling before MRI. Do not assume the device or any retained component is MR safe or MR conditional without documentation.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Axera Access System?
The Axera Access System is indicated for use in procedures requiring femoral artery access, such as neurovascular angiography and embolization.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective vascular access and closure with reduced procedural time and improved hemostasis.
What complications have been reported?
Safety data indicate 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.