Edora 8 DR-T - Dual-chamber pacemaker, rate-responsive

Nazione: Australia

Lingua: inglese

Fonte: Department of Health (Therapeutic Goods Administration)

Commercializzato da:

Biotronik Australia Pty Ltd

Classe:

AIMD

Prodotto da:

Biotronik SE & Co KG Woermannkehre 1, Berlin, D-12359 Germany

Area terapeutica:

47265 - Dual-chamber pacemaker, rate-responsive

Indicazioni terapeutiche:

Edora 8 DR-T housing is made of biocompatible titanium, welded from the outside and hermetically sealed. The ellipsoid shape facilitates ingrowth into the pectoral muscle area. The housing serves as an antipole in the case of unipolar lead configuration. Implantable Cardiac Pulse Generator, Dual Chamber, Rate Adaptive, unipolar/bipolar, IS-1 Compatible, with Home Monitoring. ProMRI? labelled (MR conditional) pacemakers are conditionally safe for use in the MRI environment. Edora is a family of implantable pacemakers that can be implanted for all bradycardia arrhythmia indications. The primary objective of the therapy consists of improving patients' symptoms that can be clinically manifested. The implantation of the pacemaker is a symptomatic therapy with the following objective: ?Compensation of bradycardia by atrial, ventricular, or AV sequential pacing

Stato dell'autorizzazione:

A

Data dell'autorizzazione:

2017-06-22