Heart's Second Chance: FDA Greenlights Abbott's Revolutionary No-Open-Surgery Mitral Valve

Landmark Approval: Abbott's Tendyne™ system, a first-of-its-kind device, receives FDA approval for mitral valve replacement without open-heart surgery.
Hope for High-Risk Patients: This breakthrough offers a vital new option for individuals with severe mitral annular calcification (MAC) who are too frail for traditional surgery^{1, 5}.
Transforming Lives: Tendyne™ is a minimally invasive solution designed to alleviate debilitating symptoms and dramatically improve quality of life for those with limited alternatives^{6, 8}.

For countless individuals trapped by severe mitral annular calcification (MAC), a crippling condition hardening the heart's crucial mitral valve, the path to relief was often blocked. Deemed too high-risk for invasive open-heart surgery, many faced a future of debilitating symptoms and limited hope^{1, 5, 8}. But now, a revolutionary breakthrough shatters these limitations: Abbott's Tendyne™ system has received landmark FDA approval.

This isn't just another medical device; it's a first-of-its-kind beacon of hope. Tendyne™ offers a minimally invasive transcatheter mitral valve replacement, meaning no open-heart surgery is required⁵. Delivered through a small incision, this self-expanding valve, recognized with an FDA Breakthrough Device designation, is uniquely designed for complex MAC cases. Its ingenious apical tethering system ensures it is securely anchored within the heart, while its availability in multiple sizes and the game-changing ability to be fully repositioned or retrieved during implantation allows surgeons to achieve the optimal outcome for patients previously left with few options³. This innovation promises to alleviate symptoms like chest pain and shortness of breath, offering a profound improvement in quality of life for those who need it most^{6, 8}. Already bearing the CE Mark in Europe since 2020, Tendyne™ solidifies Abbott's legacy in pioneering life-saving cardiac care, complementing existing therapies like MitraClip™ by providing a vital replacement option where repair is not feasible.

For U.S. important safety information about Tendyne, visit www.abbott.com/tendyneISI. For U.S. important safety information about MitraClip, visit www.abbott.com/mitraclipISI. Abbott is a global healthcare leader. Connect with them at www.abbott.com.

Heart's Second Chance: FDA Greenlights Abbott's Revolutionary No-Open-Surgery Mitral Valve

References

Stay Updated!