Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Edwards Lifesciences Pty Ltd
Class III
Edwards Lifesciences LLC One Edwards Way, Irvine, California, 92614 United States Of America
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.
A
2008-07-29