Device Dossier

VersaCross Large Access Solution - Endoscopic electrosurgical electrode, monopolar, single-use

Device Dossier for VersaCross Large Access Solution - Endoscopic electrosurgical electrode, monopolar, single-use (Endoscopic electrosurgical electrode,…

Intended purpose

The VersaCross Large Access Solution is indicated for creation of an atrial septal defect in the heart and for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.

Functional description

Includes the VersaCross RF Wire and the VersaCross Large Transseptal Dilator. Dilator is inserted through the access site and advanced over a guidewire to be positioned into vein. The 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.

TGA Public Summary