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

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - balloon expandable stent, supplied encased in a protective sheath, pre-mounted on a balloon dilatation catheter (stent delivery system)is delivered and deployed via inflation of the balloon at the site of the target lesion. using the flushing tool, the guide wire lumen is flushed before use. two radiopaque markers, located underneath the balloon, are used to fluoroscopically position the stent across the lesion. the multi-link 8 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 (length = 25 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (length = 25 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? patients with symptomatic ischemic heart disease due to lesions in saphenous vein byp

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

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - balloon expandable stent, supplied encased in a protective sheath, pre-mounted on a balloon dilatation catheter (stent delivery system)is delivered and deployed via inflation of the balloon at the site of the target lesion. using the flushing tool, the guide wire lumen is flushed before use. two radiopaque markers, located underneath the balloon, are used to fluoroscopically position the stent across the lesion. the multi-link 8 ll 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 (length = 35 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (length = 35 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? patients with symptomatic ischemic heart disease due to lesions in saphenous vein

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

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - delivery to and deployment of a pre-mounted l-605 cocr, balloon expandable stent at the target lesion. radiopaque markers, located underneath the balloon, are utilized to position stent across the lesion. the multi-link 8 sv coronary stent system is indicated for improving coronary luminal diameter in the following: patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length = 25 mm) with reference vessel diameters from 2.0 mm to 2.5 mm. patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length = 25 mm) with reference vessel diameters from 2.25 mm to 2.5 mm.

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

terumo australia pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - ultimaster sirolimus eluting coronary stent system with rapid exchange balloon delivery system consists of a balloon expandable intra-coronary l605 cobalt chromium (cocr) stent with abluminal drug eluting coating, that consists of a blend of sirolimus and poly (d,l-lactide-co-caprolactone), pre-mounted onto a high pressure, semi-compliant balloon delivery catheter. the catheter has two radiopaque markers, which fluoroscopically mark the ends of the stent to facilitate proper stent placement ultimaster sirolimus eluting coronary stent system is indicated for improving myocardial blood flow in patients with stenotic lesions in coronary arteries with a reference vessel diameter between 2.25mm and 4.0mm and up to 35mm in length

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

boston scientific pty ltd - 58771 - drug-eluting coronary artery stent, biodegradable-polymer-coated - the synergy everolimus-eluting platinum chromium coronary stent system is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. the balloon is then inflated to expand the stent to the appropriate diameter. finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position. the synergy stent system is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease, including patients with acute myocardial infarction, due to discrete de novo native coronary artery lesions. this device is mr conditional.

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

boston scientific pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - the promus premier everolimus-eluting platinum chromium coronary stent is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. the balloon is then inflated to expand the stent to the appropriate diameter. finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position. the promus premier everolimus-eluting platinum chromium coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease, including patients with acute myocardial infarction and patients with concomitant diabetes mellitus, due to discrete de novo native coronary artery lesions. the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm,28 mm, 32 mm and 38 mm) with a reference vessel diameter of 2.25 mm - 4.00 mm.

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

biotronik australia pty ltd - 53616 - bare-metal coronary artery stent - pk papyrus is a balloon-expandable covered stent that is pre-mounted on a rapid-exchange delivery system. the stent is made from a silicon carbide coated cobalt chromium alloy (l-605) and covered by a polyurethane membrane on its external surface. the stent is centered between two radiopaque markers to facilitate fluoroscopic visualization and positioning. pk papyrus is indicated for treatment of acute coronary artery perforations.

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

boston scientific pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - the promus elite everolimus-eluting platinum chromium coronary stent is mounted on a balloon expandable delivery catheter, is inserted percutaneously and advanced through the vasculature to the site of the lesion. the balloon is then inflated to expand the stent to the appropriate diameter. finally, the balloon is deflated and the balloon catheter removed, leaving the stent in position. the promus elite everolimus-eluting platinum chromium coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease, including patients with acute myocardial infarction and patients with concomitant diabetes mellitus, due to discrete de novo native coronary artery lesions. the treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm and 38 mm) with a reference vessel diameter of 2.25 mm - 4.00 mm.

Australia - Inggris - 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.