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

biotronik australia pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - enitra 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. mr conditional. enitra 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 - 47265 - dual-chamber pacemaker, rate-responsive - evity 6 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. 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, ventricular, or av sequential pacing

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

biotronik australia pty ltd - 47267 - single-chamber pacemaker, rate-responsive - evity 6 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

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

biotronik australia pty ltd - 47265 - dual-chamber pacemaker, rate-responsive - evity 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. 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, ventricular, or av sequential pacing

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

biotronik australia pty ltd - 47267 - single-chamber pacemaker, rate-responsive - 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

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 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. 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. intica neo 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 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 in the header. dx functionality also senses in the right atrium. mr conditional. intica neo 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 - 47270 - biventricular pacemaker/defibrillator - a triple chamber rate adaptive icd, with home monitoring functions, max. shock of 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 implanting in the pectoral muscle area. connections for bipolar pacing, sensing, unipolar connections and shock delivery are found in the header. mr conditional. rivacor 5 hf-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 and cardiac resynchronization therapy with multisite 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 ?cardiac resynchronization through multisite ventricular pacing ?compensation of bradycardia through av sequential pacing. hf-t devices with dx functionality are only indicated for patients not requiring atrial pacing. triple-chamber icds are indicated for patients with the following risks: ?sudden cardiac death caused by ventricular arrhythmias ?congestive heart failure with ventricular asynchrony

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

biotronik australia pty ltd - 47270 - biventricular pacemaker/defibrillator - a triple chamber rate adaptive icd, with is4 port connecting a quadripolar lv lead, home monitoring functions, max. shock of 40j and df4/is4/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 implanting in the pectoral muscle area. connections for bipolar pacing, sensing, unipolar connections and shock delivery are in the header. mr conditional. rivacor 5 hf-t qp 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 and cardiac resynchronization therapy with multisite 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 ?cardiac resynchronization through multisite ventricular pacing ?compensation of bradycardia through av sequential pacing. hf-t qp devices with dx functionality are only indicated for patients not requiring atrial pacing. triple-chamber icds are indicated for patients with the following risks: ?sudden cardiac death caused by ventricular arrhythmias ?congestive heart failure with ventricular asynchrony

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 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