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

cryolife medical (australia) company pty ltd - 62573 - aortic arch endovascular stent-graft - the amds is constructed of an uncovered nitinol wire braided stent attached proximally to a ptfe felt graft component. the distal uncovered stent component enables the stabilization of the dissection flap within the aortic arch and descending aorta stabilizing the structure of the aortic wall and promoting healing. the proximal ptfe felt component is used to buttress and strengthen the aortic tissue in preparation to perform the conventional polyester graft to aorta anastomosis. the amds is intended for aortic repair, aortic remodeling and re-expansion of the intimal flap within the ascending aorta, aortic arch, and into the descending aorta for patients with acute debakey type i aortic dissections undergoing open surgical repair within 0-14 days of diagnosis.

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

cryolife medical (australia) company pty ltd - 35281 - graft, vascular, synthetic - the e-vita open neo implant consists of a vascular graft part and a stent graft part. the vascular graft part of the e-vita open neo implant has circular crimps that provide the neces-sary form stability and allow to longitudinal stretching for adaption to the anatomy. at the vascular graft part, there is a perfusion branch which may be used for the extracorporeal perfusion during the intervention. e-vita open neo is intended for the surgical treatment of dissections or aneurysms in the aortic arch and the descending thoracic aorta with or without involvement of the ascending aorta.

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

cryolife medical (australia) company pty ltd - 35281 - graft, vascular, synthetic - the e-nside stent graft is delivered sterile, loaded in a delivery system. it is a self-expanding stent graft remaining in the body after deployment. the implant is available in various sizes which differ in their proximal and distal diameters. the e-nside taaa multibranch stent graft system is indicated for endovascular treatments of patients with thoracoabdominal aortic aneurysms.

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

cryolife medical (australia) company pty ltd - 46777 - abdominal aortic aneurysm stent - the e-tegra stent graft system consists of two main components:the e-tegra stent graft and the e-tegra delivery system, in which the e-tegra stent graft is loaded. the implants of the e-tegra stent graft system are self-expanding, endoluminal stent grafts remaining in the body after deployment. the bifurcation prosthesis and aorto-uni-iliac can be extended proximally with the aortic extension (ae). it has a cylindrical structure with a laser-cut stent with active fixation for anchoring. the e-tegra stent graft system is indicated for the endovasculartreatment of infrarenal aortic aneurysms. these aneurysms can alsoaffect the common iliac artery.

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

cryolife medical (australia) company pty ltd - 46777 - abdominal aortic aneurysm stent - the e-tegra stent graft system consists of two main components: the e-tegra stent graft and the e-tegra delivery system, in which the e-tegra stent graft is loaded. the implants of the e-tegra stent graft system are self-expanding, endoluminal stent grafts remaining in the body after deployment. the bifurcation prosthesis (mb) consists of an aortic segment as well as a long and a short iliac segment. the e-tegra stent graft system is indicated for the endovascular treatment of infrarenal aortic aneurysms. these aneurysms can also affect the common iliac artery.

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

cryolife medical (australia) company pty ltd - 46777 - abdominal aortic aneurysm stent - the e-tegra stent graft system consists of two main components: the e-tegra stent graft and the e-tegra delivery system, in which the e-tegra stent graft is loaded. the implants of the e-tegra stent graft system are self-expanding, endoluminal stent grafts remaining in the body after deployment. the contralateral leg (cl) consists of an iliac segment and has a cylindrical or conical shape. the e-tegra stent graft system is indicated for the endovascular treatment of infrarenal aortic aneurysms. these aneurysms can also affect the common iliac artery.

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

cryolife medical (australia) company pty ltd - 46777 - abdominal aortic aneurysm stent - the e-tegra stent graft system consists of two main components:the e-tegra stent graft and the e-tegra delivery system, in which the e-tegra stent graft is loaded. the implants of the e-tegra stent graft system are self-expanding, endoluminal stent grafts remaining in the body after deployment. the ipsilateral leg of the bifurcation prosthesis (mb) and the contralateral leg (cl) can be extended distally with an iliac extension(ie). the iliac extension can have a cylindrical or conical shape. the e-tegra stent graft system is indicated for the endovascular treatment of infrarenal aortic aneurysms. these aneurysms can also affect the common iliac artery.

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

cryolife medical (australia) company pty ltd - 46777 - abdominal aortic aneurysm stent - the e-tegra stent graft system consists of two main components: the e-tegra stent graft and the e-tegra delivery system, in which the e-tegra stent graft is loaded. the implants of the e-tegra stent graft system are self-expanding, endoluminal stent grafts remaining in the body after deployment. the aorto-uni-iliac (au) consists of an aortic segment with only one iliac attachment site for the secondary prosthesis. the e-tegra stent graft system is indicated for the endovascular treatment of infrarenal aortic aneurysms. these aneurysms can also affect the common iliac artery.

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

cryolife medical (australia) company pty ltd - 35281 - graft, vascular, synthetic - the e-vita open plus delivery system with loaded stentgraft is introduced into the aorta through a median sternotomy using a guide wire and advanced up to the implantation site.the self-expanding mechanism of the e-vita open plus stentgraft is triggered by retracting the outer shell of the delivery system.the stentgraft adapts itself to the shape and size of the sealing zone. the e-vita open plus stent graft system is indicated for the treatment of aneurysms, dissections and specific lesions of the thoracic aorta.

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

cryolife medical (australia) company pty ltd - 47784 - surgical adhesive/sealant, animal-derived - a two-component surgical adhesive composed of purified bovine serum albumin (bsa) and glutaraldehyde which is sterilised via gamma-irradiation. the solutions are dispensed by a controlled delivery system, applicator tips, and applicator tip extenders. the delivery device-mediated application is designed to provide reproducible mixing of the components in vitro. bioglue begins to polymerize within 20 to 30 seconds and reaches its bonding strength within 2 minutes. bioglue surgical adhesive is indicated for use as an adjunct to standard methods of surgical repair (such as sutures, staples, and/or patches) to adhere, seal, and/or reinforce soft tissue. indicated soft tissues are cardiac, vascular, pulmonary, and dural.