📊 Evidence-Based Reference
Axera Access System
Arstasis
Summary: The Axera Access System is a vascular access device designed for femoral artery access and closure. It is primarily used in neurovascular procedures. Key evidence highlights its safety and efficacy in reducing manual compression and bed rest.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K121521 ↗
Decision Date ?
June 21, 2012
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Axera Access System was cleared by the FDA through the 510(k) pathway on June 21, 2012. 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 that employs a dual arteriotomy mechanism for femoral artery access. It is intended for use in neurovascular procedures to facilitate arterial access and closure, minimizing the need for manual compression.
FDA-Cleared Indications
- For percutaneous access to the common femoral artery.
- For access and closure of the femoral artery during catheter-based vascular procedures.
- Intended to facilitate hemostasis after femoral arterial access and reduce the need for prolonged manual compression.
Clinical Applications
- Femoral arterial access for diagnostic neurovascular angiography.
- Femoral arterial access for interventional neurovascular procedures.
- Femoral artery closure following catheter-based procedures.
- Situations in which reducing manual compression or post-procedure bed rest is clinically appropriate.
Reported off-label uses
- Femoral access and closure for selected non-neurovascular interventional radiology procedures.
- Femoral access and closure for selected peripheral vascular interventions.
- Femoral access and closure for selected interventional cardiology procedures.
Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.
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 effectively reduces the need for manual compression and prolonged bed rest following femoral artery access. The device has been shown to facilitate rapid hemostasis 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 the small number of studies and the lack of long-term follow-up data. Further research is needed to fully understand the device's efficacy and safety profile across diverse patient populations.
Practical Considerations
- The device is intended for femoral artery access; ultrasound or fluoroscopic guidance may be used to identify an appropriate puncture site.
- Use requires an adequately sized and accessible common femoral artery and careful assessment for vessel disease, calcification, stenosis, or prior access complications.
- Device size and compatibility depend on the specific Axera system and the catheter or sheath used for the procedure; the current manufacturer instructions for use should be checked.
- Do not assume MRI safety from the device name alone. MRI conditions should be confirmed in the current labeling and with the treating facility.
- Potential complications include bleeding, hematoma, pseudoaneurysm, arteriovenous fistula, arterial injury, thrombosis, infection, and failure of hemostasis.
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 neurovascular procedures requiring femoral artery access and closure.
What outcomes have been reported in clinical studies?
Clinical studies have reported effective reduction in manual compression and bed rest, with rapid hemostasis achieved in neurovascular procedures.
What complications have been reported?
Safety data from evidence 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.