CE Mark for Tendyne Transcatheter Mitral Valve Implantation (TMVI) system.- Abbott

Abbott has announced that its Tendyne Transcatheter Mitral Valve Implantation (TMVI) system received CE Mark and is now approved for use in Europe . This life-changing therapy treats significant mitral regurgitation (MR) in patients requiring a heart valve replacement and provides a safe and effective solution for MR patients who are not candidates for open-heart surgery or transcatheter mitral valve repair. As the most common heart disease affecting the heart valves, MR is a debilitating, progressive and life-threatening condition in which the heart's mitral valve does not close completely, allowing blood to flow backward into the left atrium of the heart. Due to the complex nature of mitral valve disease and different patient anatomies, multiple treatment options for MR may be necessary. For patients at high-risk for open-heart surgery or in clinical situations when the mitral valve is too damaged for a successful repair with Abbott's MitraClip device, the Tendyne system offers a much-needed, alternative minimally invasive treatment option when the leaky valve needs to be replaced. The Abbott Tendyne valve is a first-of-its-kind therapy to replace the mitral valve in patients in need of symptom relief and quality-of-life improvement without open surgery and when transcatheter mitral repair is not possible. Global trial results to date have demonstrated excellent procedural safety and 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 thanks to its innovative and unique design. 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 Tendyne valve is available in multiple sizes to treat a broad range of valve anatomies. The valve is fully repositionable and retrievable during implantation, allowing for the best possible outcome for people suffering from MR and needing a valve replacement. .