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,…
- GMDN category: Transseptal access system
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.