Device Category Dossier

Aortic transcatheter heart valve bioprosthesis, stent-like framework

Device Category Dossier for Aortic transcatheter heart valve bioprosthesis, stent-like framework. Australian ARTG records, sponsors, device class —…

Transcatheter heart valves are bioprosthetic devices implanted within degenerative calcified aortic valves or failing surgical aortic valve bioprostheses using minimal invasive transcatheter implantation technique. These devices are used to relieve aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis or failure of surgical or transcatheter bioprosthetic aortic valves who are judged appropriate candidates by a heart team.