Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 17453 - catheter, valvuloplasty, balloon dilatation - the edwards transfemoral balloon catheter consists of a shaft and balloon with two radiopaque marker bands that indicate the working length of the balloon. the proximal end of the device has a "y-connector" with a balloon inflation port labelled as "balloon" and a guidewire lumen port labelled as "wire". the balloon catheter is indicated for dilation of stenotic native aortic valve leaflets.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 66209 - valve-non-specific transcatheter heart valve bioprosthesis - the edwards commander delivery system consists of a balloon catheter for deployment of the thv, and a flex catheter to aid in valve alignment to the balloon, tracking and position of the thv. the delivery system includes a tapered tip to facilitate crossing of the native valve. the handle contains a flex wheel to control flexing of the flex catheter, and a balloon lock and fine adjustment wheel to facilitate valve alignment and positioning of the valve within the native annulus. the edwards sapien 3 valve and sapien 3 ultra transcatheter heart valve, commander delivery system and accessories are indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ? 8% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the sts risk calculator).

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 45577 - mitral annuloplasty ring - the carpentier-edwards physio annuloplasty ring is constructed of elgiloy bands separated by polyester film strips and has a sewing margin that consists of a layer of silicone rubber covered with a woven polyester cloth. the mitral ring conforms to the configuration of a normal mitral annulus. the flexibility is increased in the posterior regions of the ring. along the annular plane the ring is stable with a saddle shaped curve for apposition to the aortic root. intended for the correction of mitral valve insufficiency or mixed mitral insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve. the annuloplasty ring is designed to follow the functional changes which occur during the cardiac cycle

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 60242 - aortic heart valve bioprosthesis - aortic heart valve with bovine pericardial leaflets a xenograft of bovine tissue origin that is used to repair or replace the natural aortic heart valve.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 60244 - mitral heart valve bioprosthesis - bovine mitral heart valve. a xenograft with bovine origin tissue that is used to repair or replace a natural mitral heart valve.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 35273 - cardiovascular patch, animal-derived - piece of treated bovine pericardium 10 cm x 15 cm used to close and repair cardiac septal defects or injured myocardial tissue.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 30017 - transducer, pressure, reusable - a hemodynamic monitoring device that, when used with the monitor, measures continuous cardiac output (cco) through an arterial pressure line.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 35644 - prosthesis, internal, annuloplasty, ring - used in tricuspid valve repairs, the oval tricuspid ring conforms to the configuration of a normal tricuspid orifice the edwards mc3 tricuspid annuloplasty system, model 4900, is intended for use in patients to correct annular dilatation, increase leaflet coaptation, reinforce annular suture lines, and prevent further dilatation of the annulus.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 34905 - cannula, venous - edwards lifesciences dual stage venous drainage cannulae are single-use disposable devices that are intended for drainage from the superior and inferior vena cava during short- term (<6 hours) cardiopulmonary bypass procedures. dual drainage venous return cannulae are indicated for venous cannulation so that extracorporeal circulation of the venous blood to a heart-lung machine may be achieved, for a duration of < 6 hours. they are also indicated for coronary bypass procedures where single tube venous drainage from the right atrium only is ordinarily contraindicated because of diminished caval return due to intraoperative manipulation of the heart.

Australien - engelska - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 34905 - cannula, venous - edwards lifesciences single stage venous drainage cannulae are single-use disposable devices that are intended for drainage from the superior and inferior vena cava during short- term (<6 hours) cardiopulmonary bypass procedures. venous return cannulae are intended for cannula drainage from the superior and inferior vena cava during extracorporeal circulation for a duration of < 6 hours. venous return cannulae in sizes 6 fr. (2 mm) to 18 fr. (6 mm) can be used in pediatric patients. the 40 fr. (13.3 mm) wire reinforced venous return cannula is also indicated for single tube venous drainage from the right atrium.