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

medtronic australasia pty ltd - 47932 - multiple peripheral arteries stent - the stent is indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); or lesions believed to be at high risk for restenosis following pta in the external iliac, superficial femoral, proximal popliteal or subclavian arteries. stenting is intended to improve and maintain artery luminal diameter.

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

device technologies australia pty ltd - 47932 - multiple peripheral arteries stent - a balloon-expandable cocr stent, covered with eptfe graft material, pre-mounted on the balloon of an over the wire (otw) delivery system. available in 3 stent designs. ?12 & 14mm can be maximally post-dilated with an appropriate balloon to 20mm, ?16 & 18mm can be post-dilated to 24mm & ?20 ? 24mm can be post-dilated to 30mm. compatible with 0.035? (0.89mm) guide wires. two radiopaque markers located underneath the balloon fluoroscopically identify the position of the stent on the balloon. the ?begraft aortic stent graft system? is indicated for; ? the implantation in the native and/or recurrent coarctation of the aorta (coa) on adolescent or adult patients with the following clinical conditions: -- stenosis of the aorta resulting in significant anatomic narrowing as determined by angiography or noninvasive imaging, i.e. echocardiography, magnetic resonance imaging (mri), ct scan; -- stenosis of the aorta resulting in hemodynamic alterations, resulting in systolic pressure gradient, systemic hypertension or altered left ventricular function; -- stenosis of the aorta where balloon angioplasty is ineffective or contraindicated; -- stenosis diameter <20% of the adjacent vessel diameter. stenosis that would present increased risk of vascular damage of disruption. ? and furthermore for restoring and improving the patency of the iliac arteries.

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

diverse devices pty ltd - 47932 - multiple peripheral arteries stent - indicated for the treatment of de novo or restenotic atherosclerotic lesions in peripheral arteries located under the aortic arch and for palliation of biliary tract malignant stenosis.

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

device technologies australia pty ltd - 47932 - multiple peripheral arteries stent - the system consists of; a balloon-expandable cobalt-chromium (l605) stent, covered with an eptfe graft material, which is pre-mounted on the balloon of an over the wire (otw) stent delivery system. the delivery system is compatible with 0.035? (0.89mm) guide wires and is available in usable lengths of 75cm and 120cm. two radiopaque markers located underneath the balloon identify the begraft peripheral stent position and fluoroscopically mark the working length of the balloon. the begraft peripheral stent graft system is indicated for intraluminal chronic placement in iliac and renal arteries for: ? restoring and improving the patency and ? treating aneurysms, acute perforations, acute ruptures and fistulas.

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

medtronic australasia pty ltd - 47932 - multiple peripheral arteries stent - the protege gps self expanding peripheral stent is a self expanding stent intended for permanent implantation. the stent is made of a nickel-titanium alloy (nitinol) and comes premounted on a 6f over-the-wire delivery system. the delivery system is comprised of an inner shaft and outer sheath which are locked together with a safety lock. the system as supplied includes the stent, the delivery catheter, the stent delivery system, stopcock and tubing for flushing. the protege gps self-expanding stent is indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); or lesions believed to be at high risk for restenosis following pta in the common iliac, external iliac or subclavian arteries. stenting is intended to improve and maintain artery luminal diameter.

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

vistamed pty ltd - 47932 - multiple peripheral arteries stent - intended for percutaneous intravascular implantation to maintan patency and improve luminal diamater of peripheral arteries in patients with atherosclerotic, radiation-induced and posttraumatic lesions causing vessel stenosis, of haemodynamic significance and which are intractable otherwise.

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

medtronic australasia pty ltd - 47932 - multiple peripheral arteries stent - iliac: the visi-pro balloon-expandable peripheral stent system is intended to improve luminal diameter in patients with atherosclerotic disease due to stenotic, restenotic or occluded lesions (length ? 10 cm) in the common and external iliac arteries. biliary: the visi-pro stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

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

biotronik australia pty ltd - 47932 - multiple peripheral arteries stent - it is indicated for use in patients with atherosclerotic disease of the superficial femoral, proximal popliteal and infrapopliteal arteries and for the treatment of insufficient results after percutaneous transluminal angioplasty (pta), e.g. residual stenosis and dissection.

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

medtronic australasia pty ltd - 47932 - multiple peripheral arteries stent - the protege gps self-expanding stent is indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (pta); or lesions believed to be at high risk for restenosis following pta in the common iliac, external iliac or subclavian arteries. stenting is intended to improve and maintain artery luminal diameter.

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

emergo asia pacific pty ltd t/a emergo australia - 47932 - multiple peripheral arteries stent - this device is intended for use in peripheral arteries for the repair of post percutaneous transluminal balloon angioplasty (pta) dissection(s).