Comparison of Transseptal Puncture Techniques in Animal Model

This technical report presents a comparison of the safety and efficacy of two transseptal puncture systems: the VersaCross™ RF Transseptal Solution and the FlexCath Cross™ Transseptal Solution. The study was conducted using both in vivo and ex vivo experiments on swine. The VersaCross system demonstrated a 100% success rate in transseptal puncture with significantly fewer attempts and lower power requirements compared to the FlexCath system, which achieved only 91% success and required higher energy levels. The report details the methods used for puncture, including the application of electrocautery and the measurement of mechanical force. Safety assessments revealed that the FlexCath system was associated with higher incidences of tissue coring and larger defects. The findings indicate that purpose-built RF devices improve the consistency and reliability of transseptal puncture while reducing the risk of thermal damage. This research contributes to the understanding of transseptal puncture techniques and their implications for clinical practice.