Abbott (NYSE: ABT) reported new study findings supporting the use of its Tendyne transcatheter mitral valve replacement (TMVR) system.
Tendyne offers an option for patients with mitral valves that fail to function properly due to severe mitral annular calcification (MAC). MAC stiffens the annulus ring-like structure that supports the mitral valve. This can lead to mitral regurgitation or stenosis, disrupting the heart’s ability to effectively pump blood.
Some patients with severe MAC at high risk for open-heart surgery can’t have their valve repaired with Abbott’s MitraClip. For this population, Tendyne delivers an alternative, minimally invasive way to replace the leaky (mitral regurgitation) or narrowed (stenosis) valve.
Tendyne, which uses nitinol, received FDA approval in May. Abbott then reported the first commercial implant last month.
The company shared findings from the SUMMIT-MAC pivotal trial at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. It marks the first. prospective, multi-center trial evaluating the system’s safety and effectiveness with core-lab adjudication and prespecified endpoints.
Abbott’s study had a primary endpoint of freedom from all-cause mortality and heart failure hospitalization (HFH) at 12 months. It evaluated 103 Tendyne recipients with severe MAC across 37 sites. The study met its prespecified study endpoints with 60.4% freedom from all-cause mortality and HFH at 12 months. Investigators also saw a 100% reduction to mitral regurgitation at 30 days.
Thirty-day mortality came in at 7.1%, 6.8% lower than than the Society of Thoracic Surgeons’ predicted risk of mortality. Bleeding came in as the most common serious adverse event (apical in 5.8%). Investigators determined that Tendyne addresses a significant treatment gap for mitral valve disease due to severe MAC.
Chris Waddell, Abbott’s U.S. VP for transcatheter aortic valve implantation (TAVI), said on LinkedIn:
“Tendyne TMVR was designed to offer a new treatment option for people with mitral valve disease due to severe MAC who aren’t candidates for open-heart surgery or a mitral valve repair. I’m #AbbottProud to see data supporting its life-changing potential for this patient population.”
