Transcatheter heart valve bioprosthesis implant inserter

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Dostępny od:

AA-Med Pty Ltd

Klasa:

Class Is

Wyprodukowano przez:

Vascular Innovations Co Ltd 88/38 Moo 1 345 Road Bangtanai Pakkret, Nonthaburi, 11120 Thailand

Dziedzina terapeutyczna:

66343 - Transcatheter heart valve bioprosthesis implant inserter

Wskazania:

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.

Status autoryzacji:

A

Data autoryzacji:

2023-04-20