Device Dossier

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

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

Intended purpose

ENO 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. 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. The device(s) are MR Conditional in the 1.5T and 3T MR environment.

Functional description

ENO DR Pacemaker is DDDR-type dual-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