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acqcross qx integrated transseptal dilator needle
Acutus Medical
Summary: The AcQCross Qx is an integrated transseptal dilator needle designed for reducing exchanges during transseptal access. It is primarily used in cryoballoon procedures. Key evidence highlights its potential for optimizing procedural workflow.
FDA Clearance Information
Pathway
510K
Number
K210685 ↗
Decision Date
April 6, 2021
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The AcQCross Qx Integrated Transseptal Dilator Needle by Acutus Medical was cleared via the FDA 510(k) pathway on April 6, 2021. It is classified as a Class 2 device under product code DYB.
What It Is
The AcQCross Qx is an integrated dilator-needle system designed to facilitate transseptal access by minimizing the need for exchanges. It is intended for use in procedures requiring large bore sheaths, such as cryoballoon ablations.
Clinical Applications
This device is commonly used in electrophysiology labs during cryoballoon ablation procedures to access the left atrium through the interatrial septum. It is particularly useful in scenarios where reducing procedural time and complexity is desired.
Evidence Summary
The available literature includes two studies published in 2022. These studies explore the device's application in cryoballoon procedures, focusing on procedural efficiency and safety. Study types include a pilot study and an optimization study.
Reported Outcomes
Published studies report that the AcQCross Qx system may enhance procedural efficiency by reducing the number of exchanges required during transseptal access. The device has been associated with a streamlined workflow in cryoballoon procedures.
Safety Profile
Reported complications include no specific adverse events detailed in the provided studies. Further research is needed to comprehensively assess the safety profile of the device.
Evidence Limitations
The evidence is limited to two studies with unspecified sample sizes and outcomes. Further research is needed to validate findings and explore long-term safety and efficacy in diverse patient populations.
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 procedures like cryoballoon ablations, where reducing procedural complexity is beneficial.
What outcomes have been reported in clinical studies?
Studies suggest improved procedural efficiency and workflow optimization during cryoballoon procedures.
What complications have been reported?
The studies provided do not detail specific complications, indicating a need for further safety evaluation.
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.