Abbott bags CE mark for Tendyne transcatheter mitral valve

Abbott announced that its Tendyne Transcatheter Mitral Valve Implantation (TMVI) system received CE mark. 

The device provides a minimally invasive treatment option for mitral regurgitation (MR) patients who are not candidates for open-heart surgery or transcatheter mitral valve repair.

Global trial results to date have demonstrated have shown 98.9% of Tendyne patients experienced MR elimination at discharge which was sustained through one-year in this very sick patient group.

The Tendyne TMVI system can adapt to a range of patient anatomies. The self-expanding valve is delivered through a small incision in the chest and up through the heart where it is implanted in a beating heart, replacing the person’s native mitral valve.

The valve is available in multiple sizes. They are fully repositionable and retrievable during implantation.