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…
- GMDN category: Lead, pacemaker, implantable, endocardial
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).