Evity 8 SR-T - Single-chamber pacemaker, rate-responsive

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Biotronik Australia Pty Ltd

Class:

AIMD

Manufactured by:

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

Therapeutic area:

47267 - Single-chamber pacemaker, rate-responsive

Therapeutic indications:

Evity 8 SR-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, single 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. Evity 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 or ventricular pacing

Authorization status:

A

Authorization date:

2017-06-22