Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - a dual chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and is-1/df-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are found in the header. mr conditional. intica neo 7 dr-t belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?compensation of bradycardia through av sequential pacing. dual-chamber icds are indicated for patients with the following risk: ?sudden cardiac death caused by ventricular arrhythmias

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 37265 - defibrillator, implantable, automatic, dual-chamber - a dual chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are found in the header. mr conditional. rivacor 5 dr-t belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?compensation of bradycardia through av sequential pacing. dual-chamber icds are indicated for patients with the following risk: ?sudden cardiac death caused by ventricular arrhythmias

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 35852 - defibrillator, implantable, automatic - a single chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are in the header. dx functionality also senses in the right atrium. mr conditional. rivacor 5 vr-t dx belongs to a family of implantable cardioverter-defibrillators (icd). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias with ventricular pacing. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?compensation of bradycardia through av sequential pacing. vr-t dx devices are only indicated for patients not requiring atrial pacing. single-chamber are indicated for patients with the following risk: ?sudden cardiac death caused by ventricular arrhythmias

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 35852 - defibrillator, implantable, automatic - a single chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. the ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are found in the device header. mr conditional. rivacor 7 vr-t belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias with ventricular pacing. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?compensation of bradycardia through ventricular pacing. single-chamber icds are indicated for patients with the following risk: ?sudden cardiac death caused by ventricular arrhythmias

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 35852 - defibrillator, implantable, automatic - a single chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4/is-1 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are in the header. dx functionality also senses in the right atrium. mr conditional. rivacor 7 vr-t dx belongs to a family of implantable cardioverter-defibrillators (icd). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias with ventricular pacing. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?compensation of bradycardia through av sequential pacing. vr-t dx devices are only indicated for patients not requiring atrial pacing. single-chamber are indicated for patients with the following risk: ?sudden cardiac death caused by ventricular arrhythmias

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 35852 - defibrillator, implantable, automatic - a single chamber, rate adaptive icd with home monitoring functions, max. shock energy 40j and df4 connector. biocompatible titanium housing is hermetically sealed and serves as a potential antipole during shock delivery or in the case of unipolar lead configuration. the ellipsoid shape facilitates implantation in the pectoral muscle area. the connections for bipolar pacing, sensing and shock delivery are found in the device header. mr conditional. rivacor 5 vr-t belongs to a family of implantable cardioverter-defibrillators (icds). the primary objective of the therapy is to prevent sudden cardiac death. furthermore, the device is capable of treating bradycardia arrhythmias with ventricular pacing. the implantation of an icd is a symptomatic therapy with the following objectives: ?termination of spontaneous ventricular fibrillation (vf) through shock delivery ?termination of spontaneous ventricular tachycardia (vt) through antitachycardia pacing (atp); in case of ineffective atp or hemodynamically not tolerated vts, with shock delivery ?compensation of bradycardia through ventricular pacing. single-chamber icds are indicated for patients with the following risk: ?sudden cardiac death caused by ventricular arrhythmias

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47804 - implantable cardiac monitor - it continuously and automatically records and monitors the heart rhythm. depending on the preset parameters, subcutaneous ecgs, and other data may be recorded. the patient can also trigger the recording of subcutaneous ecgs using the remote assistant iii accessory if subjectively symptomatic episodes occur. the recordings can be transmitted to the biotronik home monitoring service center. this enables physicians to perform complete diagnosis management. mr conditional. biomonitor iii is the product name of an implantable cardiac rhythm monitoring system that records subcutaneous ecgs. recording is activated both automatically and by the patient.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47804 - implantable cardiac monitor - it continuously and automatically records and monitors the heart rhythm. depending on the preset parameters, subcutaneous ecgs, and other data may be recorded. the patient can also trigger the recording of subcutaneous ecgs using the remote assistant iii accessory if subjectively symptomatic episodes occur. the recordings can be transmitted to the biotronik home monitoring service center. this enables physicians to perform complete diagnosis management. mr conditional. biomonitor iiim is the product name of an implantable cardiac rhythm monitoring system that records subcutaneous ecgs. recording is activated both automatically and by the patient.

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - 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

Australia - English - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 47267 - single-chamber pacemaker, rate-responsive - edora 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 mri conditional pacemakers are conditionally safe for use in the mri environment (mr conditional) 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 or ventricular pacing