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

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - balloon expandable stent, supplied encased in a protective sheath, pre-mounted on a balloon dilatation catheter (stent delivery system)is delivered and deployed via inflation of the balloon at the site of the target lesion. using the flushing tool, the guide wire lumen is flushed before use. two radiopaque markers, located underneath the balloon, are used to fluoroscopically position the stent across the lesion. the multi-link 8 coronary stent system is indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length = 25 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (length = 25 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? patients with symptomatic ischemic heart disease due to lesions in saphenous vein byp

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

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - balloon expandable stent, supplied encased in a protective sheath, pre-mounted on a balloon dilatation catheter (stent delivery system)is delivered and deployed via inflation of the balloon at the site of the target lesion. using the flushing tool, the guide wire lumen is flushed before use. two radiopaque markers, located underneath the balloon, are used to fluoroscopically position the stent across the lesion. the multi-link 8 ll coronary stent system is indicated for improving coronary luminal diameter in the following: ? patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length = 35 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (length = 35 mm) with reference vessel diameters from 2.5 mm to 4.0 mm. ? patients with symptomatic ischemic heart disease due to lesions in saphenous vein

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

abbott vascular division of abbott medical australia pty ltd - 34179 - stent, vascular, coronary artery - delivery to and deployment of a pre-mounted l-605 cocr, balloon expandable stent at the target lesion. radiopaque markers, located underneath the balloon, are utilized to position stent across the lesion. the multi-link 8 sv coronary stent system is indicated for improving coronary luminal diameter in the following: patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length = 25 mm) with reference vessel diameters from 2.0 mm to 2.5 mm. patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (length = 25 mm) with reference vessel diameters from 2.25 mm to 2.5 mm.

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

link orthopaedics australia pty ltd - 34076 - polyethylene acetabulum prosthesis - the lubinus x-linked polyethylene acetabular cup implant without snap fit for cementable fixation in the acetabulum used in primary hip arthroplasty. polyethylene acetabular cups are supplied with x-ray markers, made from cocrmo, for easy location on the x-ray and are suitable for use with ceramic or cocrmo heads with integrated spacers on external profile to give homogeneous cement mantle. x-linked polyethylene acetabular cup indicated for cementable fixation in the acetabulum in the treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures ? primary and secondary coxarthrosis ? osteoarthritis ? necrosis of the femoral head ? femoral neck fractures ? revision after implant loosening

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

link orthopaedics australia pty ltd - 33695 - femoral head bipolar component - vario-cup system part of mechanical reconstruction of the hip joint; consists of uhmwpe component encased in ultra-smooth polished endodur (cocrmo) outer metal casing, for articulation in bony acetabulum; used with femoral components from link hip systems. self-centering vario-cups provide functional view of position in post-op x-rays. with anti-luxation system to prevent dislocation. uhmwpe safety ring is placed in groove at entrance of polyethylene insert after assembly of components. the femoral prosthesis head component of the vario-cup prosthesis system indicated for use in treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures ? necrosis of the femoral head ? femoral neck fractures

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

link orthopaedics australia pty ltd - 34199 - polyethylene patella prosthesis - patella resurfacing components are part of the link knee prosthesis systems, for primary and revision knee surgery. the components geometry is carefully adapted to ensure a high level of congruency with the patellofemoral joint and a reproducible implantation technique for good results in knee arthroplasty. the 3-peg version for cemented fixation made from uhmwpe patella resurfacing component is a component of the link total knee replacement. patella resurfacing is an optional procedure carried out if femoropatellar syndrome is present.

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

link orthopaedics australia pty ltd - 32831 - uncoated knee femur prosthesis - the link femoral component intracondylar replacement megasystem c articulates with the tibial component of the modular bone and joint revision system megasystem-c. the component is made from cocrmo and uhmwpe, containing a patellar flange, and is equipped with an anti-luxation device. it contains an inner 12/14 female taper and is cementable the femoral component of the modular bone and joint revision system indicated for use in tumor and revision surgery intended to be used for mobility-limiting diseases, fractures or defects of the hip joint, the proximal and distal femur through the proximal tibia (only in combination with endo-model rotational and hinge knee sl or modular) which cannot be treated by conservative or osteosynthetic procedures. ? revision arthroplasty due to juxta-articular bone defects ? revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity ? revision of loosened femoral prosthesis components by peri-/subprosthetic fracture ? deformed proximal femur due to fractures or osteotomies ? correction of bone deficiencies, e.g. due to tumors ? large post-revision and post-trauma segmental bone defects oncological and revision surgery from tibial to hip area (in conjunction with rotational and hinge knee prostheses)

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

link orthopaedics australia pty ltd - 32831 - uncoated knee femur prosthesis - the link femoral component condylar replacement megasystem c articulates with the tibial component of the modular bone and joint revision system megasystem-c. the component is made from cocrmo and uhmwpe, with patella flange and is equipped with an anti-luxation device. it contains a 12/14 inner female taper and cocr screws are used for fixation the femoral component of the modular bone and joint revision system indicated for use in tumor and revision surgery intended to be used for mobility-limiting diseases, fractures or defects of the hip joint, the proximal and distal femur through the proximal tibia (only in combination with endo-model rotational and hinge knee sl or modular) which cannot be treated by conservative or osteosynthetic procedures. ? revision arthroplasty due to juxta-articular bone defects ? revision of loosened femoral prosthesis components involving extensive bone resorption of the proximal femur and widening of the medullary cavity ? revision of loosened femoral prosthesis components by peri-/subprosthetic fracture ? deformed proximal femur due to fractures or osteotomies ? correction of bone deficiencies, e.g. due to tumors ? large post-revision and post-trauma segmental bone defects oncological and revision surgery from tibial to hip area (in conjunction with rotational and hinge knee prostheses)

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

link orthopaedics australia pty ltd - 33581 - coated hip femur prosthesis, modular - standard c cementless implant follows concept of straight stem with flattened lateral shoulder. straight profile and rectangular cross section of implant gives proximal stability. hydroxyapatite coating ensures rapid integration into the bone. stem is made from ti6al4v alloy. 12/14 taper is designed for use with link? modular ceramic or metal prosthesis heads of different lengths and diameters. flattened tapered neck to increase range of motion between stem and acetabular cup component straight, cementless femoral stem is a component of hip prosthesis and is for the a total or partial hip prosthesis in osteoarthritis, posttraumatic osteoarthritis, rheumatoid arthritis, necrosis of the femoral head and fracture of the femoral neck

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

link orthopaedics australia pty ltd - 44362 - constrained polyethylene acetabular liner - self-centering polyethylene acetabular liner promotes even wear patterns and enhances dislocation resistance and are suitable for use with cocrmo heads polyethylene acetabular liner of the link bimobile cup dual mobility system for the treatment of mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures ? primary and secondary coxarthrosis ? osteoarthritis ? necrosis of the femoral head ? femoral neck fractures ? revision after implant loosening ? acetabular dysplasia