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)

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the medtronic corevalve? evolut? r system is a recapturable transcatheter aortic valve implantation system, which includes the corevalve? evolut? r transcatheter aortic valve, the enveo? r delivery catheter system, and the enveo? r loading system. the support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. the bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration. the corevalve evolut r 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 corevalve evolut r system is also indicated for patients with a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are at high or greater risk for surgical aortic valve replacement (avr) where high risk is defined as society of thoracic surgeons operative risk score ?8% or documented heart team agreement of risk for avr due to frailty or comorbidities.

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 - 66209 - valve-non-specific transcatheter heart valve bioprosthesis - the edwards commander delivery system consists of a balloon catheter for deployment of the thv, and a flex catheter to aid in valve alignment to the balloon, tracking and position of the thv. the delivery system includes a tapered tip to facilitate crossing of the native valve. the handle contains a flex wheel to control flexing of the flex catheter, and a balloon lock and fine adjustment wheel to facilitate valve alignment and positioning of the valve within the native annulus. the edwards sapien 3 valve and sapien 3 ultra transcatheter heart valve, commander delivery system and accessories are 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)

medtronic australasia pty ltd - 60242 - aortic heart valve bioprosthesis - the device consists of a polyester covered base frame and trileaflet support frame structure shaped to the trileaflet valve. the leaflets are from bovine tissue that have been cross-linked in buffered glutaraldehyde. the leaflets are inserted between the trileaflet support frame and the base frame, and then all components are securely sutured together. a sewing ring is integrated into the inflow base frame cover to allow the user to suture and seat the device in the supra-annular position. the intended purpose of the avalus bioprosthesis is to restore unidirectional blood flow through the aortic annulus by replacing a diseased or damaged heart valve.

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

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the evolut pro system is a recapturable transcatheter aortic valve replacement system, which includes the corevalve evolut pro transcatheter aortic valve, the enveo r delivery catheter system,and the enveo r loading system. the support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. the bioprosthesis is manufactured by suturing valve leaflets and an inner skirt from porcine pericardium into a tri-leaflet configuration. the corevalve evolut pro 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 corevalve evolut pro system is also indicated for patients with a stenosed, insufficient, or combined surgical bioprosthetic valve failure necessitating valve replacement who are at high or greater risk for surgical aortic valve replacement (avr) where high risk is defined as society of thoracic surgeons operative risk score ?8% or documented heart team agreement of risk for avr due to frailty or comorbidities.

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

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the medtronic evolut pro+ system is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic 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., sts predicted risk of operative mortality score ?8% or at a ?15% risk of mortality at 30 days).

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)

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the medtronic evolut fx 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 medtronic evolut fx system is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic 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., sts predicted risk of operative mortality score ?8% or at a ?15% risk of mortality at 30 days).

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

corcym pty ltd - 60242 - aortic heart valve bioprosthesis - perceval s is a bioprosthetic valve designed to replace a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery, with the unique characteristic of allowing sutureless positioning and anchoring at the implant site. perceval s prosthesis consists of a tissue component made from bovine pericardium and a self-expandable nitinol stent, which has the dual role of supporting the valve and fixing it in place. perceval s prosthesis is indicated for the replacement of a diseased native or a malfunctioning prosthetic aortic valve via open heart surgery. the prosthesis is indicated in patients who meet the following criteria: -subjects of age greater or equal to 65 years -subjects with aortic valve stenosis or steno-insufficiency