Device Dossier

NRG Transseptal Needle - Electrosurgical system electrode, active, general-purpose, single-use

Device Dossier for NRG Transseptal Needle - Electrosurgical system electrode, active, general-purpose, single-use (Electrosurgical system electrode,…

Intended purpose

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

Functional description

The Transseptal sheath is usually inserted through the right femoral vein and are then advanced over a guidewire to be positioned into the superior vena cava (SVC) under flouroscopic guidance. The needle is inserted through the sheath until the tip is just within the dilator. The needle is then connected to the RF Punture Generator and advanced through the septum into the left atrium.

TGA Public Summary