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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - a two-piece cylindrical endovascular graft consisting of proximal & distal components, constructed of woven polyester sewn to self-expanding z-stents. fully stented to provide stability and the expansile force to open the lumen of the graft during deployment. z-stents also provide attachment/seal of the graft to the vessel wall. barbs used for added fixation. radiopaque gold markers facilitate fluoroscopic visualisation. shipped preloaded onto either a 20fr or 22fr z-trak plus intro. system. intended for treatment of patients with atherosclerotic aneurysms, symptomatic acute or chronic dissections, contained ruptures, growing aneurysms and/or resulting in distal ischaemia, in the descending thoracic aorta having vascular morphology suitable for endovascular repair.

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - distal extensions used to provide additional length to the endovascular graft distally or to increase the length of overlap between components. it is deployed from an introduction system and a single locking mechanism secures the graft to the introduction until it is released. to facilitate visualisation, gold radiopaque markers are positioned on the ends of the graft. gold markers are placed on stent apices at the proximal and distal graft margins to assist with deployment accuracy. the distal extension is a component of the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: ? iliac/femoral anatomy that is suitable for access with the required introduction systems, ? nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer o with a length of at least 20mm, and o with a diameter measured outer-wall-to-outer-wall of no greater than 42mm and no less than 20mm

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the proximal component may be used to extend graft coverage proximally. this device is tapered and is fully stented to provide stability and the expansile force necessary to open the lumen of the stent graft during deployment. to assist with alignment, it has an uncovered stent. for added fixation and sealing, it has an internal sealing stent with fixation barbs that protrude through the graft material. the proximal tapered component is a component of the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: ? iliac/femoral anatomy that is suitable for access with the required introduction systems, ? nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer o with a length of at least 20mm, and o with a diameter measured outer-wall-to-outer-wall of no greater than 42mm and no less than 20mm

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the distal component may be used to extend graft coverage distally. it is fully stented to provide stability and the expansile force necessary to open the lumen of the stent graft during deployment. to assist with alignment, it has an uncovered stent. for added fixation and sealing, it has an internal sealing stent with fixation barbs that protrude through the graft. the distal component is a component of the zenith alpha thoracic endovascular graft which is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair including: ? iliac/femoral anatomy that is suitable for access with the required introduction systems ? nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer: ? with a length of at least 20mm, and ? with a diameter measured outer-wall-to-outer-wall of no greater than 42 mm and no less than 20mm

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the proximal component may be used to extend graft coverage proximally. this device is straight and is fully stented to provide stability and the expansile force necessary to open the lumen of the stent graft during deployment. to assist with alignment, it has an uncovered stent. for added fixation and sealing, it has an internal sealing stent with fixation barbs that protrude through the graft material. the proximal component is a component of the zenith alpha thoracic endovascular graft which is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including: a) iliac/femoral anatomy that is suitable for access with the required introduction systems b) nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic aneurysm or ulcer c) with a length of at least 20mm, and d) with a diameter measured outer-wall-to-outer wall of no greater than 42mm and no less than 20mm

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - this device is part of a modular system consisting of a main body, two iliac legs, main body extension and a converter. the graft modules are constructed of woven polyester fabric sewn to self-expanding nitinol stents with braided polyester and monofilament polypropelene suture. the modules are fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. the stents provide the necessary attachment and seal of the graft to the vessel wall. the zenith alpha abdominal endovascular graft is indicated for the endovascular treatment of patients with abdominal aortic or aorta-iliac aneurysms having morphology suitable for endovascular repair, inluding: a) iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 french (6.0 mm od) or 17 french (6.5 mm od) vascular introducer sheath; b) non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: - with a length of at least 15 mm, - with a diameter measured outer wall to outer wall of no greater than 32 mm and no less than 18mm, - with and angle less than 60 degrees relative to the long axis of the aneurysm, and - with and angle less than 45 degrees relative to the axis of the suprarenal aorta. c) iliac artery distal fixation site greater than 10 mm in length and 8 to 20 mm in diameter (measured outer wall to outer wall).

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - this device is part of a modular system typically consisting of a bifurcated main body and two iliac legs. it is constructed of woven polyester fabric sewn to five self-expanding nitinol z-stents and a continuous nitinol spiral stent with braided polyester and monofilament polypropylene suture. the graft is fully stented to provide stability and the expansile force necessary to open the lumen of the graft during deployment. z-stents provide the necessary attachment/seal of the graft to the wall. the zenith alpha spiral-z endovascular leg is indicated for use with the zenith aaa endovascular graft family of products, including the zenith alpha abdominal endovascular graft, zenith low profile aaa endovascular graft, zenith flex aaa endovascular graft, zenith renu aaa ancillary graft, flex aui, zenith fenestrated aaa endovascular graft, zenith branch iliac endovascular graft, and zenith aaa ancillary components, during either a primary or secondary procedure in patients who have adequate iliac/femoral access compatible with the required introduction systems. the graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorta-iliac aneurysms.

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the zenith t-branch is a tubular endovascular graft with four branches and with a covered stent at the proximal end that contains barbs for additional fixation of the device. the graft is designed to be connected with the coeliac, superior mesenteric and two renal arteries. the zenith t-branch is shipped loaded onto the h&l-b one-shot introduction system. it has a sequential deployment method with built-in features to provide continuous control of the graft throughout the deployment process. the zenith t-branch thoracoabdominal endovascular graft is indicated for the endovascular treatment of high-risk patients with thoracoabdominal aneurysms who are not amenable to open surgical repair. the patients must have morphology suitable for endovascular repair, including: a) adequate iliac/femoral access compatible with a 22 fr / 8.5 mm od introduction system, b) non-aneurysmal thoracic aorta fixation segment proximal to the aneurysm: - with an angle less than 90 degrees relative to the long axis of the aneurysm - with a length of at least 25 mm, (50 mm of wall contact is preferred) - with a diameter measured outer wall to outer wall of no greater than 30 mm and no less than 24 mm - alternatively, the zenith t-branch graft may be attached to a pre-existing endovascular graft such as the zenith tx2 taa endovascular graft. c) visceral vessel anatomy compatible with zenith t-branch, specifically: - four indispensible arteries from the abdominal viscera - all target arteries to be accessible from an antegrade approach - coeliac and superior mesenteric artery (sma) to be 6 mm to 10 mm in diameter - renal arteries to be 4 mm to 8 mm in diameter - the distance between each cuff and the corresponding arterial orifice is less than 50 mm - the line between the cuff and the arterial orifice as projected onto the vessel wall deviates by no more than 45 degrees from the long axis of the aorta.

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the zenith low profile aaa endovascular graft converter is part of a modular system consisting of a main body, main body extension and iliac legs and a converter. it is loaded onto a h&l-b one-shot introduction system and deployed using a trigger wire system. the converter can be used to assist in converting a bifurcated graft into an aortouni-iliac graft if necessary. the main body graft wire guide is used to introduce the converter into the main body. the zenith low profile aaa endovascular graft ancillary component, converter, zlc, is indicated for the treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: ? iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 french (6.0mm od) or 17 french (6.5mm od) vascular introducer sheath; ? non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o with a length of at least 15mm, o with a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm, o with an angle less than 60 degrees relative to the long axis of the aneurysm, and o with an angle less than 45 degrees relative to the axis of the suprarenal aorta. ? iliac artery distal fixation site greater than 10mm in length and 8 to 20 mm in diameter (measured outer wall to outer wall).

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

william a cook australia pty ltd - 35281 - graft, vascular, synthetic - the zenith low profile aaa endovascular graft main body extension can be used to provide additional length to the proximal portion of the endovascular graft. the main body extension utilises a 16fr or 17 fr h&l-b one-shot introduction system which contains a single trigger-wire relese mechanism and deploys the main body extension by sheath retraction and removal of the distal trigger wire. the zenith low profile aaa endovascular graft ancillary component, main body extension, (zlbe), is indicated for the treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including: ? iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity) should be compatible with a 16 french (6.0mm od) or 17 french (6.5mm od) vascular introducer sheath; ? non-aneurysmal infrarenal aortic segment (neck) proximal to the aneurysm: o with a length of at least 15mm o with a diameter measured outer wall to outer wall of no greater than 32mm and no less than 18mm o with an angle less than 60 degrees relative to the long axis of the aneurysm, and o with an angle less than 45 degrees relative to the axis of the suprarenal aorta. ? iliac artery distal fixation site greater than 10mm in length and 8 to 20mm in diameter (measured outer wall to outer wall).