Device Dossier
Mitral Advanced Performance Bileaflet Mechanical Valve Model 501DMxx series
Device Dossier for Mitral Advanced Performance Bileaflet Mechanical Valve Model 501DMxx series (Prosthesis, internal, valve, cardiac, artificial, Class…
- GMDN category: Prosthesis, internal, valve, cardiac, artificial
Intended purpose
Intended for use as a replacement valve in patients with diseased, damaged, or malfunctioning heart valves. This device may also be used to replace a previously implanted prosthetic heart valve.
Functional description
The device orifice and leaflets are constructed of pyrolytic carbon and the sewing cuff is constructed of titanium and polyester fabric for added strength and radiopacity and can be rotated for optimal positioning once implanted in the mitral position.