Device Dossier
Edora 8 DR-T - Dual-chamber pacemaker, rate-responsive
Device Dossier for Edora 8 DR-T - Dual-chamber pacemaker, rate-responsive (Dual-chamber pacemaker, rate-responsive, Class III, sponsor Biotronik). ARTG…
- GMDN category: Dual-chamber pacemaker, rate-responsive
Intended purpose
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
Functional description
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.