đź“Š Evidence-Based Reference
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 ?
510(k)
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.
FDA-Cleared Indications
- Access to the left atrium through the interatrial septum during transseptal procedures.
- Dilation of the transseptal puncture tract to facilitate placement of a compatible sheath or catheter.
- Use in procedures requiring large-bore transseptal access, according to the device labeling and compatible system instructions.
Clinical Applications
- Transseptal access for cryoballoon catheter ablation.
- Left-atrial access for electrophysiology procedures requiring a large-bore sheath.
- Creation and dilation of a transseptal access tract under fluoroscopic and, when used, echocardiographic guidance.
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.
Practical Considerations
- The device is intended to reduce exchanges by combining the transseptal needle and dilator; the compatible sheath size and system configuration must be confirmed in the current instructions for use.
- Transseptal access is typically performed through the femoral vein using fluoroscopy, with intracardiac or transesophageal echocardiography used when appropriate.
- Potential complications include bleeding, vascular injury, cardiac perforation, pericardial effusion or tamponade, air embolism, thromboembolism, and arrhythmia.
- MRI safety and conditional scanning requirements should be verified in the current FDA labeling and manufacturer instructions; do not assume the device is MR safe.
- Use is contraindicated or inappropriate when transseptal access is not clinically indicated or when the patient cannot safely undergo venous access, anticoagulation management, or the planned procedure.
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.