Device Dossier

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

Device Dossier for ENO SR Pacemaker - Single-chamber pacemaker, rate-responsive (Single-chamber pacemaker, rate-responsive, AIMD, sponsor Microport Crm).…

Intended purpose

ENO 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 environment.

Functional description

ENO SR Pacemaker is single-chamber rate responsive pacemaker. It is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient’s activity

TGA Public Summary