Device Dossier

NRG Transseptal Needle - Endoscopic electrosurgical electrode, monopolar, single-use

Device Dossier for NRG Transseptal Needle - Endoscopic electrosurgical electrode, monopolar, single-use (Endoscopic electrosurgical electrode, monopolar,…

Intended purpose

The NRG Transseptal Needle is used to create an atrial septal defect in the heart. Secondary indications include monitoring intracardiac pressures, sampling blood and infusing solutions.

Functional description

The NRG Transseptal Needle is intended to deliver radiofrequency power in a monopolar mode between its distal electrode and a return electrode. The device is loaded through a sheath/dilator set and is connected to a RF generator. The distal end of the needle contains a hole to facilitate injection of contrast solution and the monitoring of cardiac pressures.

TGA Public Summary