Device Dossier

VersaCross RF Wire - Endoscopic electrosurgical electrode, monopolar, single-use

Device Dossier for VersaCross RF Wire - Endoscopic electrosurgical electrode, monopolar, single-use (Endoscopic electrosurgical electrode, monopolar,…

Intended purpose

Indicated for creation of an atrial septal defect in the heart.

Functional description

Following vascular access, guidewire is introduced and advanced to target location. Guidewire is then exchanged for RF wire. RF wire is inserted into dilator hub and advanced through the sheath/dilator assembly to puncture site. RF wire is then advanced to make direct contact with septum. RF power is delivered from generator via RF wire. Once desired puncture is achieved, RF wire is mechanically advanced without power. Dilator is advanced over RF wire to enlarge the puncture.

TGA Public Summary