אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

cardinal health australia 503 pty ltd -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 60910 - coronary venous pacing lead - used for the permanent transvenous implantation in the coronary venous system via the coronary sinus in cardiac resynchronisation therapy as a component of an integrated system for long-term cardiac pacing together with a suitable implantable triple chamber pacemaker or lcd. conditional mr compatibility. used for permanent sensing and pacing for ventricular resynchronization.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 60910 - coronary venous pacing lead - used for the permanent transvenous implantation in the coronary venous system via the coronary sinus in cardiac resynchronisation therapy as a component of an integrated system for long-term cardiac pacing together with a suitable implantable triple chamber pacemaker or icd. conditional mr compatibility. used for permanent sensing and pacing for ventricular resynchronization.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 46535 - drug-eluting coronary artery stent - the xience pro ll everolimus eluting coronary stent systems are indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels),lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ? 65), and for treatment of both men and women. ? for the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with timi flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. the xience pro ll everolimus eluting coronary stent systems are also indicated for improving peripheral luminal diameter in the following: ? for the treatment of severe claudication or critical limb ischemia (cli) due to infrapopliteal occlusive lesions. in all cases, the treated lesion length should be less than the nominal stent length (33 mm or 38 mm) with a reference vessel diameter of ? 2.25 mm and ? 4.25 mm.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - the xience pro everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ? 65), and for treatment of both men and women. ? for the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with timi flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. in all cases, the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm) with a reference vessel diameter of ? 2.25 mm and ? 4.25 mm.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - the xience alpine everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ? 65), and for treatment of both men and women. ? for the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with timi flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. in all cases, the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter of ? 2.00 mm and ? 4.25 mm.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

abbott vascular division of abbott medical australia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - the xience xpedition 48 everolimus eluting coronary stent system is indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. ? for restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset. ? for the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (two lesions in two different epicardial vessels), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (lesions with a side branch < 2 mm in diameter or an ostial stenosis < 50%); for the treatment of elderly patients (age ? 65), and for treatment of both men and women. ? for the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions (defined as coronary artery lesions with timi flow 0 and lasting longer than 3 months); and coronary artery bifurcation lesions. in all cases, the treated lesion length should be less than the nominal stent length (48 mm) with a reference vessel diameter of ? 2.50 mm and ? 3.75 mm.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

boston scientific pty ltd -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd -

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

biotronik australia pty ltd - 60910 - coronary venous pacing lead - implantable, steroid eluting, quadripolar, coronary sinus lead, is4 connector. the lead body consists of a coil made up of several parallel wires. the insulation is composed of silicone and is covered by a polyurethane tube which improves gliding properties. atraumatic fixation with a pre-shaped two-dimensional s-curve of the distal area. suitable for coronary vessels with an internal diameter that is larger than the lead diameter. mr conditional. in combination with a compatible implantable triple chamber pacemaker or icd, this lead is indicated for the following: ? permanent, transvenous implantation in the coronary venous system via the coronary sinus of the left side of the heart ? permanent sensing and pacing of the left ventricle