أستراليا - الإنجليزية - 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).

أستراليا - الإنجليزية - 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).

أستراليا - الإنجليزية - 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).

أستراليا - الإنجليزية - 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.

أستراليا - الإنجليزية - 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 labeled endurant ii/iis stent graft diameter.

أستراليا - الإنجليزية - 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 labeled endurant ii/iis stent graft diameter.

أستراليا - الإنجليزية - 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.

المملكة المتحدة - الإنجليزية - MHRA (Medicines & Healthcare Products Regulatory Agency)

janssen-cilag ltd - rilpivirine hydrochloride - tablet - 25mg

جنوب أفريقيا - الإنجليزية - South African Health Products Regulatory Authority (SAHPRA)

janssen pharmaceutica (pty) ltd - tablet - not indicated - none