Device Dossier
NAVIGO 4LV Lead - Coronary venous pacing lead
Device Dossier for NAVIGO 4LV Lead - Coronary venous pacing lead (Coronary venous pacing lead, Class III, sponsor Microport Crm). ARTG record, intended…
- GMDN category: Coronary venous pacing lead
Intended purpose
The NAVIGO 4LV lead is for chronic left-ventricular pacing through a coronary vein. It is intended to be used in conjunction with a pacemaker or defibrillator for permanent pacing of the left ventricle for cardiac resynchronization therapy (CRT-P or CRT-D) with an IS4-LLLL port.
Functional description
NAVIGO 4LV is a quadripolar coronary venous lead, intended to be used with implantable pacemakers or defibrillators with ventricular resynchronization therapy providing chronic left ventricular pacing. The lead can be guided towards the left ventricle through a coronary vein using either the stylet or the “over-the-wire” technique. The NAVIGO 4LV leads have been tested for use in the Magnetic Resonance Imaging (MRI) environment. The leads are full body 1.5T and 3T MR conditional.