Key result
Clip2Edge TEER yields ~15% 1-year rate of mortality and heart failure hospitalization in FMR.
Why the study?
The MitraClip is the only FDA-approved TEER system for functional MR, and initial safety and efficacy data for the new Clip2Edge system are needed.
The initial study of the Clip2Edge system demonstrates reliable technical success, clinical symptom improvement, and positive left ventricular remodeling for patients with severe functional mitral regurgitation.
Early Clip2Edge data support feasibility in severe functional MR; leaves open randomized comparison to approved TEER systems.
•Transcatheter edge-to-edge repair (TEER) has now become the standard treatment option for patients with moderate to severe or severe symptomatic functional mitral regurgitation (MR) despite the guideline-directed medical therapy.•The MitraClip (Abbott Vascular, Santa Clara, California) is the only TEER system currently approved by the Food and Drug Administration for the treatment of functional MR.•This study has demonstrated the initial safety and efficacy of a new TEER device (Clip2Edge system, IasoCardiac Medical Technology Co, Ltd, Shanghai, China) for treating functional MR patients who remain symptomatic despite guideline-directed medical therapy.•This device may provide an additional treatment option for this patient population.
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Wang et al. (2026) studied Symptomatic heart failure with functional mitral regurgitation (n=129). Clip2Edge transcatheter edge-to-edge repair system was evaluated on Composite rate of all-cause mortality and heart failure hospitalization at 12 months (95% CI 8.41%, 20.69%).
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