Device Dossier

Solvia Rise SR-T - Single-chamber pacemaker, rate-responsive

Device Dossier for Solvia Rise SR-T - Single-chamber pacemaker, rate-responsive (Single-chamber pacemaker, rate-responsive, Class III, sponsor…

Intended purpose

Solvia Rise are implantable pacemakers (PM: SR-T and DR-T). A pacemaker is part of an implantable pacemaker system comprising a pacemaker and leads. The primary function of the system is the ability, first, to sense the intrinsic heart rhythm/rate and, second, to provide pacing by electrical pulses of low energy when necessary to ensure a stable heart rate or to support the intrinsic heart rate when needed. The implantation of a pacemaker is a symptomatic therapy with the following objectives: • Sensing and recording the heart rhythm and automatically detecting bradycardia (PMs) • Compensation of bradycardia through atrial or ventricular, or AV sequential pacing (PMs)

Functional description

Implantable single-chamber pacemaker that monitors the heart rhythm and automatically detects and treats bradycardia by providing electrical pulses to the heart. The housing is made of biocompatible titanium and serves as an antipole in the case of unipolar lead configuration. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. - Connector port: RV - Lead connector: IS-1 - Configuration: unipolar, bipolar

TGA Public Summary