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.

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

edwards lifesciences pty ltd - 45578 - mitral/tricuspid annuloplasty ring - the cosgrove-edwards annuloplasty system consists of two primary components ? the implantable flexible annuloplasty band and the template/lanyard assembly. the implantable annuloplasty band is composed of a silicone rubber strip compounded with barium sulphate to enable radiographic visualization. the silicone rubber strip is covered with polyester velour cloth which is sewn together with a single seam. the system can be used in mitral and tricuspid valve repairs. the cosgrove-edwards annuloplasty system, model 4600, is intended to be used in mitral and tricuspid valve repairs for 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 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 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.

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

edwards lifesciences pty ltd - 45577 - mitral annuloplasty ring - constructed of cobalt-chromium bands separated by polyester film strips and has a sewing cuff that consists of a layer of silicone rubber covered with a woven polyester cloth. transverse colored threads indicate the anterior and posterior commissures and the center of the posterior portion of the ring the carpentier-edwards physio ii ring, model 5200, is an annuloplasty ring 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.

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

edwards lifesciences pty ltd - 35644 - prosthesis, internal, annuloplasty, ring - used in tricuspid valve repairs, the ring has a waveform contour with selective flexibility of the different segments to adapt to the complex motion of the annulus. the device maintains support of the tricuspid annulus to prevent excessive dilation while adapting to the dynamic motion of the tricuspid annulus in the direction of flow during the cardiac cycle.. this reduces the stress on the anatomical structures and therefore minimizes the risk of arrhythmia and ring dehiscence. 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.

Australia - English - 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

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

edwards lifesciences pty ltd - 60244 - mitral heart valve bioprosthesis - the device is a trileaflet stent-supported bioprosthetic valve comprised of bovine pericardium mounted on a flexible frame. it is designed to be compliant at the orifice and commissures to reduce the closing loading shocks at the commissure tips and free margin of the leaflets. an elgiloy band surrounds the base of the wireform frame providing structural support for the orifice and identification radiologically. the carpentier-edwards perimount plus pericardial bioprosthesis model6900ptfx mitral is indicated for patients who require replacement of their native or prosthetic mitral valve. the device is mr conditional under 3t.

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.