Indications
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.
Contraindications
Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.
Warnings / Precautions / Adverse Events
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.
Caution
Federal law (USA) restricts this device to sale by or on the order of a physician.