Device Dossier

Solia JT - Lead, pacemaker, implantable, endocardial

Device Dossier for Solia JT - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III, sponsor Biotronik). ARTG…

Intended purpose

Solia JT is for permanent transvenous implantation in the right atrium as integrated system for long term heart pacing, when together with a suitable implantable pacemaker or ICD with pacemaker functionality.

Functional description

The lead tip has tines (polyurethane) for passive fixation in the trabeculae of the right atrium. The lead body has a J shape and consists of two coaxial coils making conduction paths for pacing and sensing between the distal pole and ring electrodes. The coils are embedded in silicone insulation. A Polyurethane tube improves gliding properties. Dexamethasone acetate at the lead tip reduces inflammation and threshold increase after implantation. The device is MR conditional (1.5T and 3T).

TGA Public Summary