Device Dossier

Sentus ProMRI OTW QP S-xx/49 - Coronary venous pacing lead

Device Dossier for Sentus ProMRI OTW QP S-xx/49 - Coronary venous pacing lead (Coronary venous pacing lead, Class III, sponsor Biotronik). ARTG record,…

Intended purpose

In combination with a compatible implantable triple-chamber pacemaker or ICD,this lead is indicated for the following: • Permanent, transvenous implantation in the coronary venous system via the coronary sinus of the left side of the heart • Permanent sensing and pacing of the left ventricle

Functional description

Implantable, steroid eluting, quadripolar, coronary sinus lead, IS4 connector. The lead body consists of a coil made up of several parallel wires. The insulation is composed of silicone and is covered by a Polyurethane tube which improves gliding properties. Atraumatic fixation with a silicone thread between the tip electrode and the ring electrode, which wedges itself directly between the vessel walls. Suitable for coronary vessels with small internal diameters. MR conditional.

TGA Public Summary