Device Dossier

VersaCross Connect Access Solution for FARADRIVE - Transseptal access system

Device Dossier for VersaCross Connect Access Solution for FARADRIVE - Transseptal access system (Transseptal access system, Class III, sponsor Boston…

Intended purpose

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

Following vascular access, the guidewire is introduced and advanced to the target location. The dilator and compatible introducer/access sheath assembly is advanced over the guidewire to the transseptal puncture site. After confirmation of the transseptal puncture, the atrial septal defect is dilated using the dilator. The dilator is then removed while keeping the transseptal puncture wire in place.

TGA Public Summary