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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
510K
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.
Clinical Applications
Commonly used in cardiac electrophysiology, the device aids in procedures requiring transseptal access, such as catheter ablation for atrial fibrillation. It is particularly useful in cases where traditional access routes are compromised.
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.
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.