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

biotronik australia pty ltd - 35223 - lead, pacemaker, implantable, endocardial - the lead tip has tines (polyurethane) for passive fixation in the trabeculae of the right ventricle or atrium. the lead body consists of two coaxial coils making conduction paths for pacing and sensing between the distal pole and ring electrodes. the coils are embedded in silicone insulation. a polyurethane tube improves gliding properties. dexamethasone acetate at the lead tip reduces inflammation and threshold increase after implantation. the device is mr conditional (1.5t and 3t). solia t is for permanent transvenous implantation in the right ventricle or right atrium as integrated system for long term heart pacing, when together with a suitable implantable pacemaker or icd with pacemaker functionality.

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

biotronik australia pty ltd - 35223 - lead, pacemaker, implantable, endocardial - an extendable/retractable electrically active tip electrode (distal pole) fixation screw fixating the lead in the myocardium. pacing and sensing occur between the distal pole and ring electrode. a polyurethane tube improves gliding properties. a steroid (dexamethasone acetate) at the lead tip reduces inflammation and threshold increase after implantation. available in 45, 53 and 60 cm, the leads coils and cables are embedded in silicone insulation. the device is mr conditional (1.5t and 3t). solia s is for permanent transvenous implantable in the right ventricle or right atrium. for use with a suitable implantable pacemaker or icd with pacemaker functionality constituting an integrated system for permanent cardiac pacing. the electrically active screw especially suitable for positioning in the atrium and patients with deteriorating ventricular trabeculae for whom passive fixation is not possible.

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

biotronik australia pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - device consists of a balloon expandable stent (permanent implant) pre-mounted on a fast exchange ptca catheter (working length=140cm). made from a cobalt chromium alloy (l-605) & covered with a layer of amorphous silicon carbide. stent strut thickness: 60?m for stent ? 2.25 to 3.0mm and 80?m for ? 3.5 to 4.0 mm. stent body surface consists of a carrier (plla) and an active substance sirolimus. to facilitate fluoroscopic visualization & positioning, stent is centred between 2 radiopaque markers. the orsiro sirolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length less than or equal to 40 mm) in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm. this device is mr conditional.

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

biotronik australia pty ltd - 35223 - lead, pacemaker, implantable, endocardial - the lead tip has tines (polyurethane) for passive fixation in the trabeculae of the right atrium. the lead body has a j shape and consists of two coaxial coils making conduction paths for pacing and sensing between the distal pole and ring electrodes. the coils are embedded in silicone insulation. a polyurethane tube improves gliding properties. dexamethasone acetate at the lead tip reduces inflammation and threshold increase after implantation. the device is mr conditional (1.5t and 3t). solia jt is for permanent transvenous implantation in the right atrium as integrated system for long term heart pacing, when together with a suitable implantable pacemaker or icd with pacemaker functionality.

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 is-1/df-1/is4 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. intica neo 7 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

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 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, unipolar connections and shock delivery are found in the device header. mr conditional. intica neo 7 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 antitachy

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 ?

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 ine

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

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

biotronik australia pty ltd - 47932 - multiple peripheral arteries stent - it is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (pta), e.g. residual stenosis and dissection.