Cardioband Mitral Reconstruction System receives CE mark approval in EU- Valtech Cardio
Valtech Cardio announced it has received CE Mark approval for its Cardioband Mitral Reconstruction System, a proprietary, implantable mitral reconstruction device with a transfemoral, transseptal delivery system for mitral valve repair in Heart Surgery.
The designation was based on the results of a multicenter feasibility trial that demonstrated the safety and effectiveness of Cardioband in mitral valve repair. Results of the study demonstrated that Cardioband is a highly effective first-line treatment option for reducing mitral regurgitation (MR) and improving quality of life scores. In a multicenter feasibility trial including more than 50 patients, Cardioband was shown to significantly reduce annular size, with significant improvement in MR. After six months of follow-up, 82% of patients (n = 22) were categorized in NYHA Class I-II, with significant improvement of quality of life (Minnesota Living With Heart Failure Questionnaire) score of 38 to 18 [p<0.05]; and had six-minute walk test score of 250 to 322 [p><0.05]). at 12 months' follow-up, 94% of patients (n="17)" had sustained mr less than or equal to 2+.>0.05]).>0.05];>
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