Singapore - engelsk - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - 1. the edwards sapien 3 system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. 2. the edwards sapien 3 system is indicated for use in patients with symptomatic heart disease due to a failing aortic bioprosthetic valve or a failing mitral surgical bioprosthetic valve (stenosed, insufficient, or combined) who are judged by a heart team 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).

Singapore - engelsk - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the edwards sapien 3 system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. the edwards sapien 3 system is indicated for use in patients with symptomatic heart disease due to a failing aortic bioprosthetic valve or a failing mitral surgical bioprosthetic valve (stenosed, insufficient, or combined) who are judged by a heart team 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).

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

edwards lifesciences pty ltd - 60242 - aortic heart valve bioprosthesis - the carpentier-edwards perimount pericardial aortic bioprosthesis is intended for use in patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their natural valve with a prosthetic one. it is also intended for use in patients with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement. in the latter case, the previously implanted prosthesis is surgically excised and replaced by the replacement prosthesis.

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

edwards lifesciences pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the edwards centera transcatheter heart valve is indicated in patients with symptomatic, severe aortic valve stenosis requiring aortic valve replacement

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

edwards lifesciences pty ltd - 60242 - aortic heart valve bioprosthesis - the edwards intuity elite valve system is a balloon expandable stainless steel cloth-covered frame which is incorporated into the inflow aspect of the valve and is implanted with the aid of a delivery system, which is used to expand the frame within the left ventricle outflow tract,and works in conjunction with the sewing ring to position and stabilise the valve at implant.

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

edwards lifesciences pty ltd - 60242 - aortic heart valve bioprosthesis - the edwards inspiris resilia aortic valve model 11500a are indicated for patients who require replacement of their native or prosthetic valve.

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

edwards lifesciences pty ltd - 16463 - sealing crimper - the crimper is used with a 2-piece crimp stopper to correctly crimp the edwards transcatheter heart valve (thv) to reduce the diameter of the thv to mount it to the delivery system.

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

edwards lifesciences pty ltd - 17541 - catheter balloon inflation system, single-use - the edwards inflation device is indicated for use in performing edwards intuity elite balloon dilation procedures to inflate the balloon, monitor the pressure within the balloon and deflate the balloon.

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

edwards lifesciences pty ltd - 63543 - cardiac implantation catheter table - the edwards pascal valve repair system is indicated for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation. the pascal system ? table is part of the edwards pascal transcatheter valve repair system.

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

edwards lifesciences pty ltd - 63542 - cardiac implantation catheter holder - the edwards pascal valve repair system is indicated for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation. the pascal system - stabilizer is part of the edwards pascal transcatheter valve repair system.