Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the carpentier-edwards physio tricuspid annuloplasty ring, model 6200, is intended for use in patients with tricuspid insufficiency, 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 - 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 - 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 - edwards oximetry central venous catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurement.

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the carpentier-edwards physio annuloplasty rings are intended for the correction of the mitral valve insufficiency or mixed mitral valve insufficiency and stenosis, where treatment does not necessitate a replacement of the natural mitral valve.

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the cosgrove-edwards annuloplasty system, model 4600, 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 - the carpentiers-edwards perimount pericardial bioprostheses is intended for use in the patients whose aortic or mitral valvular disease is sufficiently advanced to warrant replacement of their natural valve with prosthetic one. it is also intended for use in patients with a previously implanted aortic valve prosthesis which 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.

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the carpentier-edwards perimount rsr pericardial aortic bioprosthesis is intended for use in patients who require replacement of their native valve or prosthetic aortic valve.

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - the inspiris resilia aortic valve, model 11500a, is intended for use as a heart valve replacement. the inspiris resilia aortic valve, model 11500a, is indicated for patients who require replacement of their native or prosthetic aortic valve.

Singapore - English - HSA (Health Sciences Authority)

edwards lifesciences (asia) pte. ltd. - cardiovascular - indicated for the assessment of a patients hemodynamic condition through direct intercardiac and pulmonary artery pressure monitoring, cardiac output determination, and for infusing solutions. the distal (pulmonary artery) port also allows sampling of mixed venous blood for the assessment of oxygen transport balance and the calculation of derived parameters such as oxygen consumption, oxygen utilization coefficient, and intrapulmonary shunt fraction.