📊 Evidence-Based Reference
Versacross Steerable Sheath Versacross Transseptal Dilator
Baylis Medical
Summary: The VersaCross steerable sheath and transseptal dilator by Baylis Medical is used for transseptal puncture in cardiac procedures. Key evidence suggests improved catheterization efficiency.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K190688 ↗
Decision Date ?
April 17, 2019
Product Code ?
DYB
Device Class ?
Class 2
Evidence ?
0 studies
The VersaCross steerable sheath was cleared by the FDA via the 510(k) pathway on April 17, 2019. It is manufactured by Baylis Medical and classified as a Class 2 device.
What It Is
The VersaCross steerable sheath is a medical device designed for transseptal puncture, facilitating access to the left atrium during cardiac procedures. It combines a steerable sheath with a transseptal dilator to enhance procedural efficiency.
FDA-Cleared Indications
- Used to provide transseptal access to the left atrium during cardiac catheter-based procedures.
- Used with compatible guidewires, catheters, and other accessories to facilitate intracardiac access.
Clinical Applications
- Transseptal access for cardiac electrophysiology procedures.
- Access to the left atrium for catheter ablation procedures, including atrial fibrillation ablation.
- Left-sided intracardiac catheterization when access across the interatrial septum is required.
Evidence Summary
The literature includes two studies, one from 2024 and another from 2025, examining the device's efficiency and alternative access routes. Study types include RCTs and other observational designs.
Reported Outcomes
Published studies report that the VersaCross system improves left atrial catheterization efficiency and consistency. The device has been shown to be a feasible option in cases where standard venous access is not possible.
Safety Profile
Reported complications include the potential for adverse events related to transseptal puncture, though specific safety data from the studies is limited. Further research is needed to fully understand the safety profile.
Evidence Limitations
The current evidence is limited by a small number of studies and lack of comprehensive safety data. Further research is needed to confirm findings and explore long-term outcomes.
Practical Considerations
- The sheath and dilator must be used with compatible guidewires, catheters, and introducer components according to the current instructions for use.
- Transseptal puncture requires fluoroscopic and/or echocardiographic imaging and should be performed by clinicians trained in intracardiac catheterization.
- Available sizes, working lengths, curve options, and steerability depend on the specific model; clinicians should confirm the product configuration before use.
- MRI safety depends on the exact device model and whether the device remains in the patient. Consult the current labeling for MR conditions; do not assume it is MRI safe.
- Potential complications include bleeding or vascular injury at the access site, cardiac perforation, pericardial effusion or tamponade, embolism, arrhythmia, stroke, infection, and injury to nearby cardiac structures.
Frequently Asked Questions
What are the clinical indications for VersaCross steerable sheath?
The device is indicated for transseptal puncture in cardiac procedures, particularly when traditional access routes are not feasible.
What outcomes have been reported in clinical studies?
Studies report improved catheterization efficiency and feasibility in alternative access scenarios.
What complications have been reported?
Reported complications include potential adverse events related to transseptal puncture, though specific data is limited.
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.