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Indications, Safety, and WarningsIndicationsThis device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.ContraindicationsHeavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis are contraindications.Warnings, precautions, and adverse eventsOnly physicians who have received proper training in valve repair should use this device. Adverse events can include thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding, or hemorrhage. For additional information, please refer to the instructions for use provided with the product or contact your local Medtronic representative.Caution: Federal law (United States) restricts this device to sale by or on the order of a physicianUC202410620 EN

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