📊 Evidence-Based Reference
Across Transseptal Access System 406977 406978 406979 406980 406981 406982 406983 406984
Summary: The Across Transseptal Access System is a device used for transseptal access in cardiac procedures. It is primarily used in procedures requiring left atrial access. Key evidence highlights its role in improving procedural efficiency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K070417 ↗
Decision Date ?
June 5, 2007
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The Across Transseptal Access System was cleared by the FDA through the 510(k) pathway on June 5, 2007. It is manufactured by St Jude Medical and classified as a Class 2 device.
What It Is
The Across Transseptal Access System is designed to facilitate transseptal access during cardiac procedures. It is used to gain access to the left atrium, typically in procedures such as catheter ablation.
FDA-Cleared Indications
- Facilitate transseptal access to the left atrium during cardiac catheterization procedures.
- Provide a pathway for introducing compatible catheters or other devices into the left atrium.
- Use under imaging guidance by trained physicians when left atrial access is clinically required.
Clinical Applications
- Transseptal access during catheter ablation procedures for atrial fibrillation and other atrial arrhythmias.
- Left atrial pressure measurement and diagnostic cardiac catheterization.
- Access for selected left-sided structural heart procedures requiring a transseptal route.
- Delivery of compatible catheters or devices into the left atrium.
Evidence Summary
The available literature includes 10 studies, comprising various study types such as RCTs and case series. The studies span a range of clinical applications and were published up to 2025.
Reported Outcomes
Published studies report that the Across Transseptal Access System enhances procedural efficiency and safety in cardiac interventions. It is associated with improved access to the left atrium, facilitating complex procedures.
Safety Profile
Reported complications include device-related thrombus and procedural challenges, as noted in specific case studies. However, overall safety profiles are favorable in the context of its intended use.
Evidence Limitations
Current evidence is limited by the lack of large-scale randomized controlled trials specifically focused on this device. Further research is needed to explore long-term outcomes and comparative effectiveness.
Practical Considerations
- The system is available in multiple catalog configurations and sizes; the specific working length, curve, dilator, sheath, and needle should be matched to the patient's anatomy and intended procedure.
- It is typically used through venous access, most often the femoral vein, with fluoroscopy and sometimes intracardiac echocardiography or transesophageal echocardiography.
- The operator must confirm compatibility with the guidewire, catheter, sheath, and other equipment used for the procedure.
- MRI safety depends on the exact components and whether any portion remains in the patient. The device labeling and institutional MRI policy should be checked before scanning.
- Important risks include bleeding, vascular injury, pericardial effusion or tamponade, cardiac perforation, embolization, arrhythmia, stroke, and inadvertent puncture of adjacent structures. Patient-specific contraindications and anticoagulation management require physician assessment.
Frequently Asked Questions
What are the clinical indications for Across Transseptal Access System?
The device is indicated for use in procedures requiring transseptal access to the left atrium, such as catheter ablation for atrial fibrillation.
What outcomes have been reported in clinical studies?
Studies report improved procedural efficiency and safety, with successful access to the left atrium facilitating complex cardiac interventions.
What complications have been reported?
Safety data indicate potential complications such as device-related thrombus, though these are generally manageable within the clinical context.
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.