Device Dossier

Solia CSP S - Lead, pacemaker, implantable, endocardial

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

Intended purpose

Together with a compatible implantable pacemaker or ICD, this lead constitutes a device system intended for: • Bipolar or unipolar sensing of the intrinsic heart rhythm/rate and • Bipolar or unipolar pacing of the left bundle branch area by means of electrical pulses to ensure a stable heart rate or to support the intrinsic heart rate and contraction pattern. The lead also allows for pacing of the ventricular myocardium. It is implanted in the right ventricular septum using a transvenous approach. The primary function of the lead as part of the device system is to transmit the sensed intrinsic signals from the heart to the implanted 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

Transvenous implantable, steroid eluting, 6F, MR conditional bradycardia lead equipped with a ring electrode, an active fixation helix (not extendable/retractable) and IS-1 connector for electrical functionality. The tip electrode (fixation helix) and the ring electrode of Solia CSP S leads are connected to the contact pin and one of the contact rings of the IS-1 connector, respectively. They are used for sensing signals generated by the heart and delivering low voltage pulses to the heart.

TGA Public Summary