Device Dossier

VersaCross Access Solution - Transseptal access system

Device Dossier for VersaCross Access Solution - Transseptal access system (Transseptal access system, Class III, sponsor Boston Scientific). ARTG record,…

Intended purpose

The VersaCross 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 Transseptal Sheath. Sheath is inserted through the access site and advanced over a guidewire to be positioned into vein. Guidewire is removed and exchanged with RF wire. The RF wire is connected to the RF generator which uses cell vaporization and dielectric breakdown by RF energy as the mechanism of action.

TGA Public Summary