Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

unimed sdn bhd - latanoprost -

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

edwards lifesciences pty ltd - 60350 - aortic heart valve bioprosthesis/synthetic polymer aorta graft - intended for use as a replacement for the aortic heart valve and the ascending aorta. is indicated for patients who require replacement of their native or prosthetic aortic valve, and the associated repair or replacement of a damaged or diseased ascending aorta.

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.

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

medtronic australasia pty ltd - 60247 - pulmonary transcatheter heart valve bioprosthesis - the tpv consists of a heterologous (bovine) jugular vein valve sutured within a laser-welded, platinum-iridium stent with gold brazing of the welds. the tpv is available in a 16 mm & 18mm bovine jugular vein (nominal length of 30 mm & 28mm). the ds consists of a balloon-in-balloon catheter with a retractable polytetrafluoroethylene (ptfe) sheath large enough to cover the tpv after crimping. the melody tpv is intended to be used in conjunction with the ensemble ii delivery system to restore and maintain pulmonary valve competence in a dysfunctional, surgically placed pulmonary conduit or bioprosthesis using percutaneous implantation techniques. the melody tpv system is indicated for use in patients with one of the following clinical conditions: ? patients with regurgitant prosthetic right ventricular outflow tract (rvot) conduits or bioprostheses with a clinical indication for invasive or surgical intervention ? patients with stenotic prosthetic rvot conduits or bioprostheses where the risk of worsening regurgitation is a relative contraindication to balloon dilatation or stenting

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)

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the medtronic 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 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)

medtronic australasia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. it includes 3 gold radiopaque markers and are manufactured by suturing valve leaflets and an inner skirt from porcine pericardium into a tri-leaflet configuration. the bioprosthesis has a porcine pericardial tissue outer skirt (wrap), which is 1.5 cells in height and is sutured to the inflow section of the bioprosthesis. the 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 evolut fx 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)

corcym pty ltd - 60242 - aortic heart valve bioprosthesis - perceval plus is a bioprosthetic valve with the unique characteristic of allowing sutureless positioning and anchoring at the implant site. prior to implantation the prosthesis diameter is reduced to a suitable size for loading it on the holder. the valve is then positioned and released in the aortic root, where the stent design and its ability to apply a radial force to the annulus allows stable anchoring of the device perceval plus prosthesis is intended to replace a damaged native aortic heart valve or a malfunctioning aortic prosthesis via open heart surgery. it is is indicated for use in adult patients: - suffering from aortic valve stenosis or steno-insufficiency; - with a previously implanted aortic valve prosthesis that is no longer functioning adequately and requires replacement

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

abbott medical australia pty ltd - 60242 - aortic heart valve bioprosthesis - the tri-leaflet stented pericardial valve is designed for supra-annular placement in the aortic position. the valve is fabricated using a polyester-covered titanium stent. the stent and a titanium band within the sewing cuff provide radiopacity for visualisation of the valve. the valve is intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve. the valve may also be used as a replacement for a previously implanted aortic prosthetic heart valve.