Epic ™ Plus Stented Tissue Mitral Valves - Mitral heart valve bioprosthesis

Intended purpose

The Epic™ Plus Mitral Valve is intended to replace native mitral heart valves or previously implanted mitral prosthetic valves.

Functional description

During open-heart surgery the surgeon excises the native or previously implanted prosthetic heart valve and debrides the annulus and any remaining scar tissue. After removing the malfunctioning native or prosthetic heart valve, the surgeon sizes the annulus using the sizer set provided to determine the appropriate replacement valve size. The surgeon then sutures the replacement valve into the annulus and then confirms proper valve function prior to completing the implant procedure.