Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46777 - abdominal aortic aneurysm stent - the stent graft system when placed within the target lesion, provides a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the lesion from blood flow and pressure. the stent graft is preloaded into the delivery system and advanced to the aneurysm using fluoroscopic guidance. upon deployment, the stent graft self-expands to conform to the shape and size of the seal zones above and below the aneurysm. the device is a graft system indicated for the endovascular treatment of infrarenal or juxtarenal aortic or aortoiliac aneurysms (with the parallel graft technique) in patients with the following characteristics - adequate iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories; iliac distal fixation length of ?15 mm; iliac diameters with a range of 8 to 25 mm; morphology suitable for aneurysm repair; one of the following: aneurysm diameter >5 cm or aneurysm diameter of 4 to 5 cm, which has also increased in size by 0.5 cm in the last 6 months or aneurysm that is at least 1.5 times the diameter of the normal infrarenal aorta. in addition, for treatment of infrarenal abdominal aortic or aortoiliac aneurysms, the following patient characteristics apply: proximal neck length of ?10 mm or ?4 mm and <10 mm when used in conjunction with the heli-fx endoanchor system, with insignificant calcification, or insignificant thrombus with ?60? infrarenal and ?45? suprarenal angulation and a vessel diameter approximately 10% to 20% smaller than the labelled endurant ii stent graft diameter.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46777 - abdominal aortic aneurysm stent - the endurant ii stent graft system is comprised of the endurant ii stent graft and the endurant ii delivery system. the stent graft is compressed and held constrained on the delivery system as it is advanced to the aneurysm location over a guidewire. as deployment occurs , the graft self expands to cover the aneurysm. the endurant ii stent graft system is indicated for the endovascular treatment of infrarenal abdominal aortic or aortoiliac aneurysms. when placed within the aneurysm, the endurant ii stent graft provides a permanent, alternative conduit for blood flow within the patient's vasculature by excluding the aneurysmal sac from blood flow and pressure.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46777 - abdominal aortic aneurysm stent - the endurant ii stent graft system is comprised of the endurant ii stent graft and the endurant ii delivery system. the stent graft is compressed and held constrained on the delivery system as it is advanced to the aneurysm location over a guidewire. as deployment occurs , the graft self expands to cover the aneurysm. the intended use of the endurant ii stent graft system is to repair infrarenal abdominal aortic or aortoiliac aneurysms, or juxtarenal abdominal aortic or aortoiliac aneurysms (with a parallel graft technique), in an endovascular approach by providing an alternative conduit for blood flow within the patient?s vessel (aorta and iliac arteries) by excluding the aneurysm (target lesion).

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46777 - abdominal aortic aneurysm stent - the endurant ii stent graft system is comprised of the endurant ii stent graft and the endurant ii delivery system. the stent graft is compressed and held constrained on the delivery system as it is advanced to the aneurysm location over a guidewire. as deployment occurs , the graft self expands to cover the aneurysm. the intended use of the endurant ii stent graft system is to repair infrarenal abdominal aortic or aortoiliac aneurysms, or juxtarenal abdominal aortic or aortoiliac aneurysms (with a parallel graft technique), in an endovascular approach by providing an alternative conduit for blood flow within the patient?s vessel (aorta and iliac arteries) by excluding the aneurysm (target lesion).

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46777 - abdominal aortic aneurysm stent - the endurant ii stent graft system is comprised of the endurant ii stent graft and the endurant ii delivery system. the stent graft is compressed and held constrained on the delivery system as it is advanced to the aneurysm location over a guidewire. as deployment occurs, the graft self expands to cover the aneurysm. the aortic extension configurations are available if additional proximal stent graft length is needed. they have a bare proximal suprarenal stent with anchor pins. the intended use of the endurant ii stent graft system is to repair infrarenal abdominal aortic or aortoiliac aneurysms, or juxtarenal abdominal aortic or aortoiliac aneurysms (with a parallel graft technique), in an endovascular approach by providing an alternative conduit for blood flow within the patient?s vessel (aorta and iliac arteries) by excluding the aneurysm (target lesion).

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

medtronic australasia pty ltd - 46777 - abdominal aortic aneurysm stent - the abdominal tube configurations are available if additional proximal stent graft length is needed. the abdominal tube stent graft has a bare proximal suprarenal stent with anchor pins. the aortic delivery system delivers the abdominal tube stent graft configuration. the abdominal tubes are a component of the endurant ii stent graft system which is indicated for the endovascular treatment of infrarenal or juxtarenal aortic or aortoiliac aneurysms (with the parallel graft technique) in patients with the following characteristics - adequate iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices, or accessories; iliac distal fixation length of ?15 mm; iliac diameters with a range of 8 to 25 mm; morphology suitable for aneurysm repair; one of the following: aneurysm diameter >5 cm or aneurysm diameter of 4 to 5 cm, which has also increased in size by 0.5 cm in the last 6 months or aneurysm that is at least 1.5 times the diameter of the normal infrarenal aorta. in addition, for treatment of infrarenal abdominal aortic or aortoiliac aneurysms, the following patient characteristics apply: proximal neck length of ?10 mm or ?4 mm and <10 mm when used in conjunction with the heli-fx endoanchor system, with insignificant calcification, or insignificant thrombus with ?60? infrarenal and ?45? suprarenal angulation and a vessel diameter approximately 10% to 20% smaller than the labelled endurant ii stent graft diameter.

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - it consists of eptfe & fep, supported by nitinol wire along its external surface. a sleeve constrains the endoprosthesis on the leading end of the delivery catheter. deployment initiates from the trunk end of the delivery catheter, which is supplied with the endoprosthesis. after deployment, the eptfe/fep sleeve remains in situ between the endoprosthesis and the vessel wall the gore? excluder? aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: ? adequate iliac/femoral access ? infrarenal aortic neck treatment diameter range of 19 ? 32mm and a minimum aortic neck length of 15mm ? proximal aortic neck angulation ? 60? ? iliac artery treatment diameter range of 8 - 25mm and iliac distal vessel seal zone length of at least 10mm the aortic and iliac extender endoprostheses are intended to be used after deployment of the gore? excluder? aaa endoprosthe

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - the contralateral leg endoprosthesis consists of eptfe and fep, supported by nitinol wire along its external surface. an eptfe sleeve is used to constrain the endoprostheses on the leading edge of the delivery catheter. deployment is initiated from the leading (aortic) end and proceeds toward the trailing (iliac) end of the delivery catheter, which is supplied with the endoprosthesis. the gore? excluder? aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: ? adequate iliac/femoral access ? infrarenal aortic neck treatment diameter range of 19 ? 32mm and a minimum aortic neck length of 15mm ? proximal aortic neck angulation ? 60? ? iliac artery treatment diameter range of 8 - 25mm and iliac distal vessel seal zone length of at least 10mm the aortic and iliac extender endoprostheses are intended to be used after deployment of the gore? excluder? aaa en

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - it consists of eptfe & fep, supported by nitinol wire along its external surface. a radiopaque marker denotes the recommended minimum overlap with the iliac limb of the excluder endoprosthesis. a sleeve constrains the endoprosthesis on the leading end of the delivery catheter. deployment initiates from the aortic end of the delivery catheter, which is supplied with the endoprosthesis. after deployment, the eptfe/fep sleeve remains in situ between the endoprosthesis and the vessel wall the gore? excluder? aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: ? adequate iliac/femoral access ? infrarenal aortic neck treatment diameter range of 19 ? 32mm and a minimum aortic neck length of 15mm ? proximal aortic neck angulation ? 60? ? iliac artery treatment diameter range of 8 - 25mm and iliac distal vessel seal zone length of at least 10mm the aortic a

Avstralija - angleščina - Department of Health (Therapeutic Goods Administration)

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - trunk-ipsilateral leg endoprostheses consists of eptfe and fep, supported by nitinol wire along its external surface. nitinol anchors and an eptfe/fep sealing cuff are located at the aortic end of the trunk. an eptfe sleeve is used to constrain the endoprostheses on the leading edge of the delivery catheter. deployment is initiated from the leading (aortic) end and proceeds toward the trailing (iliac) end of the delivery catheter, which is supplied with the endoprosthesis. the gore? excluder? aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below: ? adequate iliac/femoral access ? infrarenal aortic neck treatment diameter range of 19 ? 32mm and a minimum aortic neck length of 15mm ? proximal aortic neck angulation ? 60? ? iliac artery treatment diameter range of 8 - 25mm and iliac distal vessel seal zone length of at least 10mm the aortic and iliac exte