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versacross transseptal sheath
Baylis Medical
Summary: The VersaCross transseptal sheath by Baylis Medical is used for transseptal puncture in cardiac procedures. It is designed to improve procedural efficiency and safety. Key evidence highlights its use in reducing procedural complexity and risks.
FDA Clearance Information
Pathway
510K
Number
K183655 ↗
Decision Date
May 20, 2019
Product Code
DYB
Device Class
Class 2
Evidence
0 studies
The VersaCross transseptal sheath received FDA 510(k) clearance on May 20, 2019. It is manufactured by Baylis Medical and is classified as a Class 2 device.
What It Is
The VersaCross transseptal sheath is a medical device used to facilitate transseptal puncture during cardiac procedures. It combines a steerable sheath with a radiofrequency wire to enhance procedural efficiency and safety.
Clinical Applications
Commonly used in catheter-based cardiac interventions, the VersaCross transseptal sheath is employed in procedures requiring left atrial access, such as atrial fibrillation ablation and left atrial appendage closure.
Evidence Summary
The available literature includes 11 studies, comprising randomized controlled trials and retrospective analyses, conducted between 2024 and 2026. These studies evaluate the device's efficiency and safety in clinical settings.
Reported Outcomes
Published studies report that the VersaCross transseptal sheath improves procedural efficiency by reducing the need for sheath exchanges. It has been shown to enhance the safety and efficacy of left atrial appendage closure and atrial fibrillation ablation procedures.
Safety Profile
Reported complications include the potential for serious complications during transseptal puncture, although the use of the VersaCross system has been associated with improved safety profiles compared to traditional methods.
Evidence Limitations
Current evidence is limited by the relatively short follow-up periods and small sample sizes in some studies. Further research is needed to assess long-term outcomes and to compare the device with emerging technologies.
Frequently Asked Questions
What are the clinical indications for VersaCross transseptal sheath?
The VersaCross transseptal sheath is indicated for use in transseptal puncture during cardiac procedures requiring left atrial access, such as atrial fibrillation ablation and left atrial appendage closure.
What outcomes have been reported in clinical studies?
Clinical studies have reported improved procedural efficiency and safety, with reduced need for sheath exchanges and enhanced outcomes in left atrial appendage closure and atrial fibrillation ablation.
What complications have been reported?
Safety data from evidence indicate potential complications during transseptal puncture, but the VersaCross system has shown improved safety compared to traditional methods.
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.