Device Dossier
Solia T - Lead, pacemaker, implantable, endocardial
Device Dossier for Solia T - Lead, pacemaker, implantable, endocardial (Lead, pacemaker, implantable, endocardial, Class III, sponsor Biotronik). ARTG…
- GMDN category: Lead, pacemaker, implantable, endocardial
Intended purpose
Solia T is for permanent transvenous implantation in the right ventricle or 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 ventricle or atrium. The lead body 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).