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

edwards lifesciences pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the edwards sapien 3 transcatheter heart valve (thv) is comprised of a balloon-expandable, radiopaque, cobalt-chromium alloy frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate (pet) inner skirt, and a pet outer skirt. the certitude delivery system is designed to facilitate transapical and transaortic access for implantation of the thv. the edwards sapien 3 valve, edwards certitude delivery system, and accessories are indicated for use in patients with severe, symptomatic, calcific aortic valve stenosis who are judged by a heart team, to be at intermediate or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality greater than or equal to 3% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical comorbidities unmeasured by the sts risk calculator).

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.

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.

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 - 66209 - valve-non-specific transcatheter heart valve bioprosthesis - the edwards sapien 3 ultra transcatheter heart valve (thv) system consists of the edwards sapien 3 ultra thv and delivery systems. the edwards sapien 3 ultra valve is comprised of a balloon-expandable, radiopaque, cobalt-chromium frame, trileaflet bovine pericardial tissue valve, and polyethylene terephthalate inner and outer fabric skirts. the commander delivery system components are intended for use via transfemoral, subclavian/axillary access routes. the edwards sapien 3 ultra transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. the edwards sapien 3 and sapien 3 ultra transcatheter heart valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, 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 - English - Department of Health (Therapeutic Goods Administration)

edwards lifesciences pty ltd - 66209 - valve-non-specific transcatheter heart valve bioprosthesis - the edwards sapien 3 transcatheter heart valve (thv) is comprised of a balloon-expandable, radiopaque, cobalt-chromium alloy frame, a trileaflet bovine pericardial tissue valve, a polyethylene terephthalate (pet) inner skirt, and a pet outer skirt. the commander delivery system components are intended for use via transfemoral, subclavian/axillary access routes. the edwards sapien 3 transcatheter heart valve system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. the edwards sapien 3 and sapien 3 ultra transcatheter heart valve system is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) of a surgical or transcatheter bioprosthetic aortic valve or surgical bioprosthetic mitral valve who are judged by a heart team, including a cardiac surgeon, 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). the edwards sapien 3 transcatheter heart valve (thv) system with edwards commander delivery system is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (rvot) conduit or surgical bioprosthetic valve in the pulmonic position with ? moderate regurgitation and/or a mean rvot gradient of ? 35 mmhg

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

edwards lifesciences pty ltd - 60242 - aortic heart valve bioprosthesis - the edwards intuity elite valve system is an implantable surgical heart valve bioprosthesis, a delivery system and an inflation device. when used together as intended these system components allow minimally invasive surgical implantation of the edwards intuity elite heart valve into the native aortic annulus. the valve is indicated for patients whose aortic valvular disease is sufficiently advanced to warrant replacement of their native valve with a prosthetic valve.

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

edwards lifesciences pty ltd - 58865 - vascular introducer kit - the edwards esheath introducer set is an expandable sheath (esheath) that provides access into the target vessel while maintaining hemostasis and temporarily enlarges its diameter to allow for passage of a device. the edwards esheath introducer set is intended for introduction of interventional devices into the vascular system. the product is intended for use by physicians trained and experienced in interventional techniques. standard techniques for placement of vascular access sheaths should be employed.