Abbott Receives FDA Approval for Tendyne™, First-of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery

Core Insights - Abbott has received FDA approval for its Tendyne™ transcatheter mitral valve replacement (TMVR) system, aimed at treating patients with mitral valve disease, particularly those with severe mitral annular calcification (MAC) [1][7] - The Tendyne system provides a minimally invasive alternative for patients who are high-risk for open-heart surgery and cannot be treated with the MitraClip™ device [2][7] - The innovative design of the Tendyne system allows for adaptability to various patient anatomies, with a self-expanding valve that can be repositioned and retrieved during implantation [3][4] Company Overview - Abbott is a global healthcare leader with a diverse portfolio that includes diagnostics, medical devices, nutritionals, and branded generic medicines, serving over 160 countries [6] - The approval of Tendyne enhances Abbott's structural heart portfolio, which focuses on less invasive treatment options for heart diseases [4][7] - Abbott has over two decades of experience in mitral valve technology, contributing to the development of life-changing medical devices [4]