đź“Š 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
510K
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.
Clinical Applications
Commonly used in neurovascular angiography, the Axera Access System provides an alternative to traditional manual compression techniques. It is particularly useful in procedures requiring rapid hemostasis and reduced patient recovery time.
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.
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.