VersaCross Large Access Solution - Transseptal access system

Intended purpose

The VersaCross Large Access Solution is indicated for creation of an atrial septal defect in the heart and for use in procedures where access to the left atrium via the transseptal technique is desired.

Functional description

Includes the VersaCross RF Wire and the VersaCross Large Transseptal Dilator. Dilator is inserted through the access site and advanced over guidewire to be positioned into vein. Guidewire is removed and exchanged with RF wire. The RF wire is connected to the connector cable which is then connected to the RF generator. The mechanism of action for the RF wire is cell vaporization and dielectric breakdown by RF energy.