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

w l gore & associates (australia) pty ltd - 66383 - intravascular occluding/stent-graft post-dilation balloon catheter - a compliant polyurethane balloon is mounted on the leading end of a 3 lumen catheter shaft. termination of the leading end is an atraumatic catheter leading tip for smooth transition from the guidewire to catheter. radiopaque markers indicate the proximal and distal end of the balloon which aid in placement under fluoroscopy. both of the lumens facilitate balloon catheter preparation, inflation and deflation. at the trailing end is a dual port y-arm which allows for over-the-wire access. the gore? molding and occlusion balloon catheter (mob) is intended to serve as a balloon catheter accessory device. ballooning of a stent graft may improve molding of the graft material and fixation of the stent graft to the vessel wall. balloon occlusion of a large diameter vessel may provide hemostasis until vessel repair may be achieved.

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

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - the internal iliac component (iic) is a component of the gore? excluder? iliac branch endoprosthesis (ibe). the iic is loaded onto a delivery catheter and is used to extend into the internal iliac artery. the gore? excluder? internal iliac component is a component of the gore? excluder? iliac branch endoprosthesis (ibe). the gore? excluder? iliac branch endoprosthesis (ibe) is intended to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with an iliac or aortoiliac aneurysm, who have appropriate anatomy, including: 1. adequate iliac / femoral access 2. minimum common iliac diameter of 17 mm at the proximal implantation zone of the ibe 3. external iliac artery treatment diameter range of 6.5 ?25 mm and seal zone length of at least 10 mm 4. internal iliac artery treatment diameter range of 6.5 ?13.5 mm and seal zone length of at least 10 mm

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

w l gore & associates (australia) pty ltd - 46777 - abdominal aortic aneurysm stent - the iliac branch component is a component of the gore? excluder? lliac branch endoprosthesis (ibe). the ibc is a bifurcated iliac branch device with an external iliac leg and an internal iliac artery gate. the ibc is placed in the common iliac at a level that allows the gate of the ibc access to the internal iliac artery. it will treat external iliac artery diameters of 6.5? 13.5mm and is loaded onto a delivery catheter. the gore? excluder? iliac branch component is a component of the gore? excluder? iliac branch endoprosthesis (ibe) which is intended to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with an iliac or aortoiliac aneurysm, who have appropriate anatomy, including: 1. adequate iliac / femoral access 2. minimum common iliac diameter of 17 mm at the proximal implantation zone of the ibe 3. external iliac artery treatment diameter range of 6.5 ? 25 mm and seal zone length of at least 10 mm 4. interna

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

w l gore & associates (australia) pty ltd - 44756 - abdominal hernia surgical mesh, composite-polymer - the biomaterial is a composite mesh comprised of a non-absorbable macroporous knit constructed of monofilament polytetrafluoroethylene (ptfe) fibers. the visceral surface is a bioabsorbable synthetic nonporous film comprised of poly (glycolide:trimethylene carbonate) copolymer (pga:tmc). the parietal surface is a bioabsorbable synthetic porous fibrous structure comprised of pga:tmc copolymer. gore? synecor intraperitoneal biomaterial is designed for intraperitoneal placement. the gore? synecor intraperitoneal biomaterial device is intended for use as a non-absorbable reinforcing or bridging material with placement between parietal and visceral tissue.

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

w l gore & associates (australia) pty ltd - 31744 - cardiovascular patch, synthetic - the device is a durable, easy to handle, synthetic patch designed for optimal tissue ingrowth while minimizing aneurysmal dilation in a wide variety of cardiovascular applications. constructed from multidirectional strength eptfe, the patch is designed to resist aneurysmal dilation and optimize tissue ingrowth. the gore tex cardiovascular patch is intended for use in carotid artery and congenital heart defect patching.

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

w l gore & associates (australia) pty ltd - 45418 - cardiac occluder - the gore? cardioform asd occluder (system) consists of an implantable occluder and a delivery system. the occluder is comprised of a platinum-filled nickel-titanium (nitinol) wire frame covered with expanded polytetrafluoroethylene (eptfe). the eptfe includes a hydrophilic surface treatment to facilitate echocardiographic imaging of the occluder and surrounding tissue during implantation. the gore? cardioform asd occluder is a permanently implanted medical device intended to close an ostium secundum atrial septal defect (asd).

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

w l gore & associates (australia) pty ltd - 66619 - peripheral artery endovascular stent-graft, drug-coated - a balloon-expandable, endoluminal endoprosthesis consisting of a 316l surgical grade stainless steel stent and an eptfe and fep graft. its surface is coated with an immobilized heparin surface (cbas? heparin surface) which consists of cbas? covalently attached to a polymeric base matrix consisting of polyethyleneimine (cbas?-polymin) and dextran sulphate. the stent is pre-mounted on a delivery system equipped with a semi-compliant balloon. the gore? viabahn? vbx balloon expandable endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5 mm - 13 mm and lesion lengths up to 110 mm, including lesions at the aortic bifurcation.

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

w l gore & associates (australia) pty ltd - 44688 - mesh, polymeric, biodegradable - rectangular sheets of porous, fibrous mesh. the instructions for use indicate that this device is a tailorable, synthetic, bioabsorbable material intended to be a temporary bridge of defects until the bioabsorbable nature of the device allows the body to fill the defect with native tissue. in repairs requiring high strength, a permanent overlay patch is strongly recommended. the gore bio-a tissue reinforcement is intended for use in the reinforcement of soft tissue.

Australia - English - 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

Australia - English - 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