This 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.
Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.
Only 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 (USA) restricts this device to sale by or on the order of a physician.