Distinct designs, complementary strategies: Tendyne and SAPIEN M3 in transcatheter mitral valve replacement

Transcatheter mitral valve replacement (TMVR) has emerged as a transcatheter treatment option for selected patients with mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair. Among dedicated TMVR devices, the Tendyne and SAPIEN M3 systems are the two clinically approved tech platforms with CE Mark and FDA approval. We comprehensively dissect their distinct design features, procedural characteristics, clinical outcomes, and associated complication profiles. Furthermore, we evaluate their respective patient selection criteria and long-term prognostic implications to facilitate evidence-based clinical decision-making for patients with severe MR. Beyond current metallic prostheses, this review extends to the future horizons of TMVR, specifically highlighting the emerging paradigm of tissue-engineered valvular stents and biodegradable scaffolds as potential solutions to overcome current limitations in prosthetic durability and biocompatibility.

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Publication Details

Journal
Frontiers in Cardiovascular Medicine
Published
2026-11-11
DOI
https://doi.org/10.3389/fcvm.2026.1966140
Primary Topic
Cardiac Valve Diseases and Treatments
Type
article
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article

Distinct designs, complementary strategies: Tendyne and SAPIEN M3 in transcatheter mitral valve replacement

G. Warnecke, Derk Frank, David J. Meier, Georg Lutter et al.
Frontiers in Cardiovascular Medicine
Cardiac Valve Diseases and Treatments
article

Distinct designs, complementary strategies: Tendyne and SAPIEN M3 in transcatheter mitral valve replacement

G. Warnecke, Derk Frank, David J. Meier, Georg Lutter, Stephanie Sellers, Tim Attmann, Thomas Puehler, Xiling Zhang, Nina Pommert, Won Kim, Jacob Voran, Zhaoyang Ye
article en

Abstract

Transcatheter mitral valve replacement (TMVR) has emerged as a transcatheter treatment option for selected patients with mitral regurgitation (MR) who are unsuitable for surgery or transcatheter edge-to-edge repair. Among dedicated TMVR devices, the Tendyne and SAPIEN M3 systems are the two clinically approved tech platforms with CE Mark and FDA approval. We comprehensively dissect their distinct design features, procedural characteristics, clinical outcomes, and associated complication profiles. Furthermore, we evaluate their respective patient selection criteria and long-term prognostic implications to facilitate evidence-based clinical decision-making for patients with severe MR. Beyond current metallic prostheses, this review extends to the future horizons of TMVR, specifically highlighting the emerging paradigm of tissue-engineered valvular stents and biodegradable scaffolds as potential solutions to overcome current limitations in prosthetic durability and biocompatibility.

Frontiers in Cardiovascular MedicineVol. 13
University of British Columbia (CA), Centre Hospitalier Universitaire Vaudois (CH), University Hospital Schleswig-Holstein (DE), German Centre for Cardiovascular Research (DE), Centre for Heart Lung Innovation (CA), University of Lausanne (CH)
Cardiac Valve Diseases and Treatments
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