Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - 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

Singapore - English - 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 - English - 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).

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the mitris resilia mitral valve, model 11400m, is intended for use as a heart valve replacement. the mitris resilia mitral valve, model 11400m, is indicated for the replacement of native or prosthetic mitral heart valves.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

Australia - English - 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.

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the pericardial patch is intended to augment the patient’s own pericardium to assist in closure following heart surgery.

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the valve is indicated for patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their native valve with a prosthetic valve. these devices are also intended for use in patients with a previously implanted aortic valve that requires replacement. in the latter case, the previously implanted prosthesis is surgically excised and replaced with the model 8300ab valve. the delivery system is indicated for introduction of the valve into the patient’s native annulus.