Device Dossier

Alizea SR Pacemaker - Single-chamber pacemaker, rate-responsive

Device Dossier for Alizea SR Pacemaker - Single-chamber pacemaker, rate-responsive (Single-chamber pacemaker, rate-responsive, Class III, sponsor…

Intended purpose

ALIZEA SR Pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree AV block; symptomatic bilateral bundle branch block; symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; Bradycardia-tachycardia syndrome to prevent symptomatic Bradycardia or some forms of symptomatic tachyarrhythmias; vasovagal syndromes or hypersensitive carotid sinus syndromes. Rate adaptive pacing in patients who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or activity. The device(s) are MR conditional in the 1.5T and 3T MR environments only.

Functional description

ALIZEA SR Pacemaker Pacemaker is a rate responsive single chamber pacemaker. The devices automatically respond to bradycardia by providing atrial and/or ventricular pacing through the delivery of electrical impulses. The pacemakers are also equipped with physiological sensor(s).

TGA Public Summary