đź“Š Evidence-Based Reference
acqcross qx integrated transseptal dilator needle
Acutus Medical
Summary: The AcQCross Qx Integrated Transseptal Dilator Needle by Acutus Medical is designed for transseptal access in cardiac procedures. It reduces the need for exchanges during procedures. Key evidence highlights its use in cryoballoon procedures.
FDA Clearance Information
Pathway
510K
Number
K220047 ↗
Decision Date
February 8, 2022
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The AcQCross Qx Integrated Transseptal Dilator Needle was cleared via the FDA 510(k) pathway on February 8, 2022. It is manufactured by Acutus Medical and classified as a Class 2 device under product code DYB.
What It Is
The AcQCross Qx is an integrated transseptal dilator and needle system designed to facilitate transseptal access in cardiac procedures. It is intended to streamline the process by reducing the number of exchanges required during the procedure.
Clinical Applications
This device is commonly used in procedures requiring transseptal access, such as cryoballoon ablation for atrial fibrillation. It is particularly useful in scenarios where minimizing procedural steps is beneficial.
Evidence Summary
The available literature includes two studies published in 2022. These studies explore the use of the AcQCross Qx system in cryoballoon procedures, focusing on its safety and procedural efficiency.
Reported Outcomes
Published studies report that the AcQCross Qx system effectively reduces the number of exchanges needed during transseptal access in cryoballoon procedures. The system has been associated with improved procedural workflow and efficiency.
Safety Profile
Reported complications include no significant adverse events directly attributed to the device in the available studies. The safety profile appears favorable, but further research is needed to confirm these findings.
Evidence Limitations
The current evidence is limited to a small number of studies, primarily focusing on cryoballoon procedures. Further research is needed to explore its use in other clinical settings and to establish long-term safety and efficacy.
Frequently Asked Questions
What are the clinical indications for AcQCross Qx Integrated Transseptal Dilator Needle?
The device is indicated for use in transseptal access during cardiac procedures, such as cryoballoon ablation for atrial fibrillation.
What outcomes have been reported in clinical studies?
Studies report improved procedural efficiency and reduced need for exchanges during transseptal access.
What complications have been reported?
No significant adverse events have been directly attributed to the device in the studies reviewed.
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.