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

biotronik australia pty ltd - 47263 - biventricular pacemaker - enitra 8 hf-t qp 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 resynchronization therapy (crt) pace generator; triple chamber; rate adaptive; unipolar/bipolar; is4 compatible; 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 ?additional triple-chamber features: resynchronization of ventricular chamber contraction via biventricular pacing

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

biotronik australia pty ltd - 47263 - biventricular pacemaker - enitra 8 hf-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 resynchronization therapy (crt) pace generator; triple chamber; rate adaptive; unipolar/bipolar; is-1 compatible; 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 ?resynchronization of ventricular chamber contraction via biventricular pacing

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 - 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. acticor 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 ?comp

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

biotronik australia pty ltd - 47805 - implantable cardiac monitor patient programmer - remote assistant iii is an accessory for the implantable cardiac monitor biomonitor iii/biomonitor iiim. pressing the trigger key sends a signal to the monitor. if the monitor successfully receives the signal, it will record and store an ecg. remote assistant iii indicates a successful or unsuccessful recording using the behaviour of the signal transmission led before it automatically turns off. remote assistant iii is powered by 2 batteries that are non-replaceable. the remote assistant iii is an accessory for the biomonitor iii/biomonitor iiim that can be used to manually trigger the recording of an ecg.

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

biotronik australia pty ltd - 35853 - lead, defibrillator, implantable - the lead body consists of a coil made embedded in silicone. it has a rv shock coil and the tip is an extendable /retractable screw (distal pole), for fixating in the myocardium. bipolar sensing in the atrium with 2 atrial ring electrodes, sensing and pacing in the ventricle, between the distal pole and ventricular ring electrode. the leads coating improves gliding properties. steroid reduces inflammation and threshold increase after implantation. mr conditional. in combination with a compatible icd, this lead is designed for the following: ? permanent sensing and pacing in the right ventricle ? permanent sensing in the right atrium ? delivery of defibrillation / cardioversion therapies

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

biotronik australia pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - orsiro mission 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 ? 40mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets: ? acute coronary syndrome (acs) ? st-elevation myocardial infarction (stemi) ? diabetes mellitus (dm) ? complex lesions (b2/c) ? high bleeding risk (hbr) ? long lesions (ll) (e.g. ? 20 mm) ? small vessels (sv) (e.g. ? 2.75 mm) ? multi-vessel disease (mvd) ? male/female ? old patients (e.g. > 65 y)

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

biotronik australia pty ltd - 36336 - remote control, foot-switch - a foot-operated switch (pedal) used by the operator to activate the medical device to which it is connected to.

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

biotronik australia pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - a drug-eluting balloon-expandable stent (permanent implant) pre-mounted on a rapid-exchange ptca catheter delivery system (usable length=140cm). 2 stent configurations: small & medium. stent is made from cobalt chromium alloy (l-605), covered with a thin layer of amorphous silicon carbide. stent body surface consists of a carrier (plla) & an active substance sirolimus. stent is positioned between 2 radiopaque markers located on delivery system used for fluoroscopic visualization. mr conditional. orsiro mission 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 ? 40 mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets: ? acute coronary syndrome (acs) ? st-elevation myocardial infarction (stemi) ? diabetes mellitus (dm) ? complex lesions (b2/c) ? high bleeding risk (hbr) ? long lesions (ll) (20 to 40 mm) ? small vessels (sv) (2.25 to 2.75 mm) ? multi-vessel disease (mvd) ? male/female ? patients > 65 years.

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

biotronik australia pty ltd - 17184 - catheter, angioplasty, balloon dilatation - it is indicated to dilate stenosis in the external iliac, femoral, popliteal and infrapopliteal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. it is also recommended for post-dilation of balloon expandable and self-expanding stents in the peripheral vasculature.