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

medtronic australasia pty ltd - 60247 - pulmonary transcatheter heart valve bioprosthesis - the harmony transcatheter pulmonary valve (tpv) system is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation (i.e., severe pulmonary regurgitation as determined by echocardiography and/or pulmonary regurgitant fraction ? 30% as determined by cardiac magnetic resonance imaging) who have a native or surgically-repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.

Australia - angielski - 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.

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

abbott medical australia pty ltd - 60246 - mitral transcatheter heart valve bioprosthesis - the tendyne apical pad is available in a large and a small size. it is comprised of a peek (polyether ether ketone) button covered by a double velour polyster (pet) fabric. the nitinol leader and tether are threaded through the apical pad to affix the pad to the epicardial surface of the heart near the apex. the cam portion of the peek button is moveable to lock and unlock the apical pad to the tether. the tendyne apical pad is intended to secure the valve after tendyne mitral valve delivery and system withdrawal.

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

abbott medical australia pty ltd - 60246 - mitral transcatheter heart valve bioprosthesis - the tendyne mitral valve delivery system consists of tendyne loading system, tendyne delivery system, tendyne pad positioning system, tendyne stand components and non-sterile, reusable tendyne loading stand and tendyne weight. the loading system collapses the valve into a loading tube. the delivery system introduces the sheath tip through the ventricular myocardium to the mitral annulus to facilitate deployment of the valve. the pad positioning system fastens apical pad to the braided tether. the tendyne mitral valve delivery system is intended for preparation, loading, delivery and securement of the tendyne mitral valve and the tendyne apical pad.

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

abbott medical australia pty ltd - 60246 - mitral transcatheter heart valve bioprosthesis - the tendyne retrieval system recaptures and collapses the valve for removal from the body during the procedure if the size or final position relative to the native annulus is suboptimal. the tendyne retrieval system is intended for retrieving the tendyne mitral valve during the procedure, if required.

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

abbott medical australia pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the navitor? valve is a pericardial, tri-leaflet valve, mounted inside a self-expanding stent that is radiopaque. the naviseal? cuff provides the sealing area for implantation and provides paravalvular leak reduction by filling any potential voids between the native valve and the stent. the valve is designed to be implanted in the native calcific aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve. indicated for transcatheter aortic valve implantation through transfemoral access in patients with symptomatic severe native aortic stenosis who are considered high or extreme risk for surgical aortic valve replacement (avr).

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

abbott medical australia pty ltd - 60246 - mitral transcatheter heart valve bioprosthesis - the tendyne mitral valve is a bioprothesis designed for transapical implantation within the native mitral valve. the valve has three pericardial leaflets sewn onto a circular, self-expanding frame. the inner frame is sewn inside a self-expanding outer frame. the outer frame helps orient the prosthesis inside the native mitral valve. indicated for the treatment of the native mitral valve without prior mitral valve intervention in patients with symptomatic (nyha class iii or iv) severe mitral valve regurgitation, a life expectancy between 1 and 5 years, left ventricular ejection fraction (lvef) ? 30%, left ventricular end-diastolic dimension (lvedd) ? 7.0 cm, who do not have severe mitral annular calcification and are deemed not suitable for surgical repair or replacement or transcatheter mitral repair who have secondary mr and are symptomatic despite maximally-tolerated guideline directed medical therapy (including cardiac resynchronization therapy, if indicated).

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

boston scientific pty ltd - 60245 - aortic transcatheter heart valve bioprosthesis, stent-like framework - the acurate neo2 loading kit is intended to load the acurate neo2 valve onto the acurate neo2 delivery system.

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

aa-med pty ltd - 66343 - transcatheter heart valve bioprosthesis implant inserter - the hydra aortic valve loading system is intended to be used as part of the hydra transcatheter aortic valve system. the hydra transcatheter aortic valve system is indicated for patients with severe degenerative aortic stenosis presenting a high predictable operative mortality risk for surgical aortic valve replacement. the hydra valve transcatheter aortic valve implantation necessitates valve replacement of the native aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve and presenting with femoral access vessels with diameters ? 5mm for 22 mm & 26mm heart valve and ? 5.5mm for 30mm heart valve and anatomical dimensions of the aortic annulus diameter between 18mm to 27mm. the loading system does not come into contact with patients and is only used to load the valve into the delivery catheter.

Australia - angielski - 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).