Solia S - Lead, pacemaker, implantable, endocardial

Intended purpose

Together with a compatible implantable pacemaker or ICD, Solia S constitutes a device system intended for: - Bipolar or unipolar sensing of the intrinsic heart rhythm/rate and - Bipolar or unipolar pacing of the right atrium, ventricle or - Bipolar or unipolar pacing of the left bundle branch area via the right ventricular septum (Solia S 53 cm, 60 cm variants only) by means of electrical pulses to ensure a stable heart rate or to support the intrinsic heart rate and contraction pattern. The lead is implanted via a transvenous approach in one of the following anatomic locations: - Right atrium - Right ventricle - Left bundle branch area via the right ventricular septum (Solia S 53 cm, 60 cm variants only) The primary function of the lead as part of the device system is to transmit the sensed intrinsic signals from the heart to the active device and the electrical pulses generated by the pacemaker or ICD to the heart. There is no secondary function of the lead. In order to avoid increasing pacing thresholds, a steroid eluting collar is located at the lead tip reducing myocardial inflammation after the implantation and subsequent fibrosis.

Functional description

An extendable/retractable electrically active tip electrode (distal pole) fixation screw fixating the lead in the myocardium. Pacing and sensing occur between the distal pole and ring electrode. A Polyurethane tube improves gliding properties. A steroid (Dexamethasone acetate) at the lead tip reduces inflammation and threshold increase after implantation. Available in 45, 53 and 60 cm, the leads coils and cables are embedded in silicone insulation. The device is MR conditional (1.5T and 3T).