Device Dossier
On-X Aortic Conform-X Prosthetic Heart Valve - Prosthesis, internal, valve, cardiac, artificial
Device Dossier for On-X Aortic Conform-X Prosthetic Heart Valve - Prosthesis, internal, valve, cardiac, artificial (Prosthesis, internal, valve, cardiac,…
- GMDN category: Prosthesis, internal, valve, cardiac, artificial
- Sponsor: Device Technologies
Intended purpose
The On-X Aortic Conform-X valve is indicated for replacement of a diseased native or prosthetic heart valve in the aortic position when implantation of a mechanical heart valve is the treatment of choice.
Functional description
Bileaflet aortic mechanical heart valve consisting of orifice housing & 2 leaflets. Orifice inflow area's flared inlet designed to reduce flow turbulence. Outflow rim's leaflet guards designed to protect leaflets in closed position. Leaflets rotate around tabs located in inner circumference of orifice ring. Sewing cuff attachment to orifice allows for rotation of sewing cuff in situ during implantation. Provided with standard or extended holder to provide guidance of valve into cardiac annulus.