GALI SonR CRT-D 2811 - Biventricular pacemaker/defibrillator

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Microport Crm Pty Ltd

Class:

AIMD

Manufactured by:

MicroPort CRM S.r.l Via Crescentino sn, Saluggia, VC, 13040 Italy

Therapeutic area:

47270 - Biventricular pacemaker/defibrillator

Therapeutic indications:

An implantable cardioverter defibrillator equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. The device can be programmed and interrogated with a compatible MicroPort dedicated programmer, using a compatible MicroPort dedicated programming head for bi-directional telemetry. It can also be equipped with the RF wireless technology which enables remote monitoring. Connector: Atrium SonR; R Ventricle IS-1 bipolar; L ventricle IS-1 bipolar. GALI SonR CRT-D and GALI CRT-D are implantable cardiac resynchronization therapy defibrillators (CRT-D) used in combination with pacing and defibrillating leads. The devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial and ventricular leads and analyze the heart rhythm based on selectable detection parameters. The devices provide simultaneous or sequential biventricular pacing using a LV electrode, and automatically detect ventricular tachyarrhythmias (VT/VF) and provide treatment with defibrillation, cardioversion, and antitachycardia pacing therapies through the delivery of shocks and electrical impulses. The devices also respond to bradycardia by providing atrial and/or ventricular pacing. Indications for use: - Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable sustained VT after evaluation to define the cause of the event and to exclude any completely reversible causes. - Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or unstable. - Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained VT or ventricular fibrillation induced at electrophysiological study. - Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial infarction and with symptomatic heart failure or LV dysfunction. - Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure. - Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and inducible ventricular fibrillation or sustained VT at electrophysiological study. Biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological therapy, with reduced LVEF and wide QRS.

Authorization status:

A

Authorization date:

2022-11-24