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.
Federal law (USA) restricts these devices to sale by or on the order of a physician.
For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at this website medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.