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

edwards lifesciences pty ltd - 17846 - catheter, intravascular, guiding - the guide sheath set includes a steerable guide sheath and introducer. the guide sheath provides left atrial access. it has a hydrophilic coating and a rotational control knob which actuates the flexion mechanism to position the guide sheath at the target location. the introducer is compatible with a 0.035 inch (0.89mm) guidewire. the edwards pascal valve repair system is indicated for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation. the pascal system - guide sheath is part of the edwards pascal transcatheter valve repair system.

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

edwards lifesciences pty ltd - 57790 - mitral valve clip - the implant system consists of the steerable catheter (outermost layer), the implant catheter (innermost layer), and the pascal implant. the implant system percutaneously delivers the pascal implant to the valve via a femoral vein access using a transvenous, transseptal approach. the implant is deployed and secured to the leaflets of the valve, acting as a filler in the regurgitant orifice. the primary components of the implant are the spacer, paddles, and clasps made from nitinol. the edwards pascal valve repair system is indicated for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation. the pascal system - implant system is part of the edwards pascal transcatheter valve repair system.

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

edwards lifesciences pty ltd - 57790 - mitral valve clip - the implant system consists of the steerable catheter (outermost layer), the implant catheter (innermost layer), and the implant (implant model 10000ism). the implant system percutaneously delivers the implant to the valve via a femoral vein access using a transvenous approach. the implant is deployed and secured to the leaflets of the valve, acting as a filler in the regurgitant orifice. the primary components of the implant are the spacer, paddles, and clasps made from nitinol. the edwards pascal valve repair system is indicated for the percutaneous reconstruction of an insufficient mitral valve through tissue approximation. the pascal system - pascal ace implant system is part of the edwards pascal transcatheter valve repair system.

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

edwards lifesciences pty ltd - 60244 - mitral heart valve bioprosthesis - the mitris resilia mitral valve is a stented tri-leaflet prosthetic heart valve comprised of resilia bovine pericardial tissue. this low-profile valve is based on the edwards perimount valve design with a nitinol wire form. the valve is mounted on a retainer with a holder system attached to the valve. intended for use as a heart valve replacement. the device is indicated for patients who require replacement of their native or prosthetic mitral valve.

Singapur - Englisch - 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.

Singapur - Englisch - 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.

Singapur - Englisch - 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.

Singapur - Englisch - 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.

Singapur - Englisch - 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.

Singapur - Englisch - 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.