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

edwards lifesciences pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the edwards centera transcatheter heart valve is indicated in patients with symptomatic, severe aortic valve stenosis requiring aortic valve replacement

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

edwards lifesciences pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - a heart valve with introducer and delivery system for implantation in to native aortic valve.

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

edwards lifesciences pty ltd - 60242 - aortic heart valve bioprosthesis - the edwards inspiris resilia aortic valve model 11500a are indicated for patients who require replacement of their native or prosthetic valve.

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

edwards lifesciences pty ltd - 60242 - aortic heart valve bioprosthesis - the inspiris resilia aortic valve, model 11500a is a stented trileaflet valve comprised of resilia bovine pericardial tissue that is mounted on a flexible frame. the valve is stored under dry packaging conditions and consequently does not require rinsing prior to implantation. the inspiris resilia aortic valve is intended for use as a heart valve replacement.

Australia - Kiingereza - 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).

Singapoo - Kiingereza - 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.

Singapoo - Kiingereza - HSA (Health Sciences Authority)

medtronic international, ltd. - cardiovascular - the avalus bioprosthesis is indicated for the replacement of a diseased, damaged, or malfunctioning native or prosthetic aortic valve.

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

boston scientific pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the acurate neo2 aortic valve, in combination with the acurate neo2 transfemoral delivery 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.