Australia - inglese - 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 - a balloon expandable, drug coated stent pre-mounted on rapid exchange delivery system. stent acts as scaffold to open the blockage in artery; polymers coated over stent provide a drug reservoir and control release profile of the anti-proliferative drug. two radiopaque markers underneath balloon mark working length of balloon and expanded stent length. two proximal delivery system shaft markers indicate relative position of delivery system to the brachial or femoral guiding catheter. the xience xpedition? 48 everolimus eluting coronary stent system is indicated for improving coronary artery 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 treatment of patients with high bleeding risk (hbr) under dual antiplatelet therapy (dapt) as short as 28 days. ? 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.

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

bio-excel australia pty ltd - 56285 - drug-eluting coronary artery stent, carbon-coated - the cre8? device consists of a sirolimus eluting coronary stent firmly held on the distal end of a semi-compliant balloon catheter. two radio-opaque platinum markers at either end of the stent enable accurate positioning on the lesion to be treated. the rapid-exchange type balloon catheter provides a safe means for delivering the coronary stent to the lesion to be treated. the coronary stent is indicated for the treatment of stenotic lesions in coronary arteries and coronary artery bypasses to maintain vessel patency. this device is mr conditional.

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

bio-excel australia pty ltd - 56285 - drug-eluting coronary artery stent, carbon-coated - the cre8? device consists of a sirolimus eluting coronary stent firmly held on the distal end of a semi-compliant balloon catheter. two radio-opaque platinum markers at either end of the stent enable accurate positioning on the lesion to be treated. the rapid-exchange type balloon catheter provides a safe means for delivering the coronary stent to the lesion to be treated. the coronary stent is indicated for the treatment of stenotic lesions in coronary arteries and coronary artery bypasses to maintain vessel patency. this device is mr conditional.

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

bio-excel australia pty ltd - 56285 - drug-eluting coronary artery stent, carbon-coated - the cre8? device consists of a sirolimus eluting coronary stent firmly held on the distal end of a semi-compliant balloon catheter. two radio-opaque platinum markers at either end of the stent enable accurate positioning on the lesion to be treated. the rapid-exchange type balloon catheter provides a safe means for delivering the coronary stent to the lesion to be treated. the coronary stent is indicated for the treatment of stenotic lesions in coronary arteries and coronary artery bypasses to maintain vessel patency. this device is mr conditional.

Australia - inglese - 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 - xience sierra is a pre-mounted l-605 cobalt chromium (cocr) alloy stent with a coating that consists of a blend of the anti-proliferative drug everolimus and polymers. two radiopaque markers, located underneath the balloon, fluoroscopically mark the working length of the balloon and the expanded stent length. two proximal delivery system shaft markers indicate relative position of the delivery system to the end of the brachial or femoral guiding catheter. the xience sierra everolimus eluting coronary stent system is indicated for improving coronary artery 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 treatment of patients with high bleeding risk (hbr) under dual antiplatelet therapy (dapt) as short as 28 days. ? 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.

Australia - inglese - 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 - xience skypoint is a medical device that will deliver and deploy a balloon-expandable, drug-coated 605 stent in de novo and restenotic native arteries to improve coronary artery luminal diameter.the mode of action is mechanical opening of stenosed vessels. the radiopaque balloon markers are used to position the stent in the target lesion. the balloon is then inflated to deploy the stent, followed by withdrawal of the delivery system once stent position and full deployment have been confirmed. the xience skypoint everolimus eluting coronary stent system is indicated for improving coronary artery 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 treatment of patients with high bleeding risk (hbr) under dual anti-platelet therapy (dapt) as short as 28 days. ? 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. additional indication applicable for xience skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): ? for the treatment of patients presenting with left main coronary artery lesions. in all cases for ? xience skypoint ((2.0 ? 4.0 mm, 8.0 - 38 mm) and (4.5 - 5.0 mm, 12 ? 33mm)): 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 ? 5.25 mm. ? xience skypoint (2.5 ? 4.0 mm, 48 mm): the treated lesion length should be less than the nominal stent length (48 mm) with a reference vessel diameter of ? 2.50 mm and ? 4.25 mm.

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

abbott vascular division of abbott medical australia pty ltd - 53616 - bare-metal coronary artery stent - the graftmaster rx coronary stent graft is constructed using a sandwich technique, whereby an ultra-thin layer of expandable polytetrafluoroethylene (ptfe) is placed between two graftmaster stentswhich are then pre-mounted on a balloon catheter delivery system. the stents are fabricated from medical grade 316l stainless steel. the graftmaster delivery system is a rapid exchange co-axial design with the balloon and stent graft at the distal end of the catheter. the graftmaster rx is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of: ?? acute coronary artery perforation ?? acute coronary artery rupture patients being considered for stent graft implantation should be acceptable for coronary artery bypass graft surgery, and / or for coronary balloon angioplasty with ischemic heart disease due to discrete de novo or restenotic native coronary lesions.

Irlanda - inglese - HPRA (Health Products Regulatory Authority)

intervet ireland limited - bovine rotavirus, strain uk-compton, serotype g6 p5 (inactivated); bovine coronavirus; escherichia coli, strain o101:k99:f41, fimbrial adhesin f5 and f41, inactivated - emulsion for injection - . - bovine rotavirus + bovine coronavirus + escherichia - cattle - immunological - inactivated vaccine

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

medtronic australasia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - the resolute onyx stent is manufactured from a composite material of cobalt alloy and platinum iridium alloy.the delivery system consists of a balloon-expandable intracoronary stent premounted on the resolute onyx rx delivery system with a catheter.the resolute onyx stent with the active drug zotarolimus is intended to reduce the incidence of restenosis in coronary interventions. the resolute onyx stent system is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (ptca) with a reference vessel diameter of 2.0 mm to 5.0 mm. the resolute onyx stent is indicated for the treatment of the following patient and lesion subsets: ? one month of dual antiplatelet therapy (dapt) in high bleeding risk (hbr) patients, including patients who are unable to tolerate long term dapt ? diabetes mellitus ? multivessel disease ? acute coronary syndrome (acs) ? acute myocardial infarction (ami) ? unstable angina (ua) ? bifurcation lesions ? in-stent restenosis (isr) ? chronic total occlusions (cto) ? total occlusions (to) ? left main (lm) ? small vessel (sv) the resolute onyx stent is intended to improve coronary luminal diameters of either single or multiple vessels as an adjunct to coronary interventions and to reduce restenosis. the stent is intended as a permanently implanted device.

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

medtronic australasia pty ltd - 56284 - drug-eluting coronary artery stent, non-biodegradable-polymer-coated - the onyx frontier stent is manufactured from cobalt platinum iridium alloy. the delivery system consists of a balloon-expandable intracoronary stent premounted on the delivery system with a catheter; for stent sizes 2.0?4.0mm and 4.5 and 5.0mm, the stent is delivered by the onyx frontier and resolute onyx rapid exchange (rx) delivery system, respectively. the onyx frontier stent with the active drug zotarolimus is intended to reduce the incidence of restenosis in coronary interventions. the stent is intended to improve coronary luminal diameters of either single or multiple vessels, as an adjunct to coronary interventions and to reduce restenosis. the stent is intended as a permanently implanted device. the onyx frontier stent system is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (ptca) with a reference vessel diameter of 2.0 mm to 5.0 mm. the stent is indicated for the treatment of the following patient and lesion subsets: one month of dual antiplatelet therapy (dapt) in high bleeding risk (hbr) patients, including patients who are unable to tolerate long-term dapt diabetes mellitus multivessel disease acute coronary syndrome (acs) acute myocardial infarction (ami) unstable angina (ua) bifurcation lesions in-stent restenosis (isr) chronic total occlusions (cto) total occlusions (to) left main (lm) small vessel (sv)