SUMMIT-MAC: Tendyne System Improves Mortality in MAC, With Paul Sorajja, MD

Patients with severe mitral annular calcification (MAC) who underwent transcatheter mitral valve replacement with Abbott’s Tendyne implant exhibited substantially reduced all-cause mortality and heart failure hospitalization, based on the SUMMIT-MAC interventional trial.1

The Tendyne system includes multiple sizes to accommodate for a range of patient anatomies. The valve is self-expanding, delivered through an incision in the chest and advanced into the heart to replace the mitral valve. Tendyne is also totally repositionable and retrievable during implantation.2

The editorial team at HCPLive spoke with Paul Sorajja, MD, associate director of the Banner – University Medicine Heart Institute and professor of medicine at the University of Arizona, to discuss the results of SUMMIT-MAC and how the Tendyne system may revolutionize this otherwise difficult-to-treat disease.

“As the first of its kind, Tendyne is quite novel, because up until now we had no knowledge of what a dedicated TMVR device would look like in terms of outcomes for these patients,” Sorajja told HCPLive. “The results exceeded expectations; we had excellent technical success.”

SUMMIT-MAC is the first prospective clinical trial designed to assess Tendyne’s efficacy in patients with severe MAC. All included patients had severe MAC with significant mitral valve dysfunction and were at high surgical risk. An echocardiography laboratory performed independent assessments of mitral disease, and adverse events were judged by an independent clinical events committee. The study’s primary endpoint was freedom from all-cause mortality and heart failure hospitalization at 12 months post-procedure.1

A total of 103 patients were ultimately included, with a mean age of 78 +/- 6.5 years. All patients underwent treatment with Tendyne, as either mitral regurgitation or stenosis was present in nearly every patient at baseline. Technical success from the implant was achieved in 94.2%. Investigators noted a 30-day mortality of 6.8%.1

The primary endpoint of freedom from all-cause mortality and heart failure hospitalization was met, which reached 60.4% at 12 months (performance goal: 43%; P = .0002). Heart failure symptoms (NYHA Class I/II, 30.6% vs 87.5%, paired baseline vs 12 months; P <.0001) and quality of life (mean paired increase in the Kansas City Cardiomyopathy Questionnaire overall summary, 18.7 +/- 24.4 points; P <.0001) also both increased.1

Ultimately, this trial was a core component in the US Food and Drug Administration’s approval of Tendyne, announced by Abbott in May 2025.2

“The key next steps are to ensure that the commercial outcomes match what we observed in the clinical trial, which means greater attention to even more operator education, patient selection, and being very meticulous about how the procedure is done,” Sorajja said. “I think as long as we keep an eye on those things, I think this will have a really strong role in our patients with severe MAC.”

References

1. Sorajja, P, Thourani, V, Rogers, J. et al. Transcatheter Mitral Valve Replacement for Severe Mitral Annular Calcification: Primary Outcomes from the SUMMIT-MAC Study. JACC. null2025, 0 (0). https://doi.org/10.1016/j.jacc.2025.10.025

2. Kong C. Abbott Receives FDA Approval for Tendyne, First-Of-Its-Kind Device to Replace the Mitral Valve Without Open-Heart Surgery. Abbott. May 27, 2025. Accessed December 1, 2025. https://abbott.mediaroom.com/2025-05-27-Abbott-Receives-FDA-Approval-for-Tendyne-TM-,-First-of-Its-Kind-Device-to-Replace-the-Mitral-Valve-Without-Open-Heart-Surgery