Device Dossier

VersaCross Steerable Access Solution - Transseptal access system

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

Intended purpose

The VersaCross Steerable Access Solution is indicated for creation of an atrial septal defect in the heart and for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum

Functional description

Includes the VersaCross RF Wire and the VersaCross Steerable 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