- Abbott (ABT, Financial) receives FDA approval for Tendyne™, a first-of-its-kind transcatheter mitral valve replacement system.
- Tendyne™ offers a minimally invasive solution for patients with severe mitral annular calcification (MAC).
- This approval enhances Abbott's portfolio of structural heart therapies in the U.S.
Abbott (ABT) has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its innovative Tendyne™ transcatheter mitral valve replacement (TMVR) system. This groundbreaking device is specifically designed to treat mitral valve disease in patients with severe mitral annular calcification (MAC) who are not suitable candidates for open-heart surgery.
The Tendyne system provides a novel treatment option by utilizing a self-expanding valve delivered through a small chest incision directly into the heart. The valve is fully repositionable during the implantation process, allowing for optimal placement and improved patient outcomes. It is also available in various sizes to suit different patient anatomies.
The FDA approval of Tendyne™ positions Abbott as a leader in the field of structural heart therapies, addressing a significant unmet medical need for high-risk patients with MAC. This advancement expands Abbott's comprehensive mitral valve portfolio, which also includes the MitraClip™ system for mitral repair, offering physicians and patients a wide range of treatment possibilities.
"Tendyne is a much-needed addition to our comprehensive U.S. structural heart portfolio, offering less invasive treatment options for a range of heart diseases," said Sandra Lesenfants, senior vice president of Abbott's structural heart business. "This approval builds on our more than two decades of mitral valve leadership, demonstrating our commitment to developing first-of-their-kind devices that truly change – and save – people’s lives."
Abbott's dedication to advancing healthcare technologies is further reflected in their broad portfolio spanning diagnostics, medical devices, nutritionals, and branded generic medicines, serving people in over 160 countries worldwide.
