ULYS DR 2510 - Defibrillator, implantable, automatic, dual-chamber

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Microport Crm Pty Ltd

Classe:

AIMD

Fabricado por:

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

Área terapêutica:

37265 - Defibrillator, implantable, automatic, dual-chamber

Indicações terapêuticas:

ULYS DR is an implantable dual-chamber cardioverter defibrillator. It is equipped with an accelerometer to allow adaptation of pacing to suit the patient?s activity. It can be programmed and interrogated with a compatible MicroPort dedicated programmer, using a compatible MicroPort dedicated programming head for bi-directional telemetry. It is also equipped with the RF wireless technology which enables remote monitoring. Connector: atrium IS-1 bipolar; ventricle IS-1 bipolar, 2 DF-1. ULYS DR is a dual chamber implantable cardioverter defibrillators (ICD) used in combination with pacing and defibrillating lead(s). The devices sense and record the electrical activity of the patient's heart using the electrodes of the implanted atrial (for DR models only) and right ventricular leads and analyze the heart rhythm based on selectable detection parameters. The devices 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. ULYS DR is indicated in: - 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.

Status de autorização:

A

Data de autorização:

2022-11-24