Device Dossier

Alizea DR Pacemaker - Dual-chamber pacemaker, rate-responsive

Device Dossier for Alizea DR Pacemaker - Dual-chamber pacemaker, rate-responsive (Dual-chamber pacemaker, rate-responsive, Class III, sponsor Microport…

Intended purpose

ALIZEA DR 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. The device(s) are MR conditional in the 1.5T and 3T MR environments only. Dual-chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony.

Functional description

Alizea DR Pacemaker is a rate responsive dual 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