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<h2>Indications, Safety, and Warnings</h2> <h3>Indications for use</h3> <p>The CG Future™ annuloplasty ring and CG Future™ annuloplasty band are indicated for the reconstruction or remodeling of pathological mitral valves. Valvular insufficiency or stenosis may be corrected by appropriate repair and annular remodeling.</p> <h3>Contraindications</h3> <p>Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.</p> <h3>Warnings/precautions/adverse events </h3> <p>Only physicians who have received proper training in valve repair should use this device. Adverse events can include: uncorrected or recurrent regurgitation, stenosis, ring or band dehiscence, hemolysis (even with mild regurgitation), low cardiac output, heart block, systolic anterior motion (SAM) and left ventricular outflow tract obstruction (LVOTO), damage to coronary arteries, damage to coronary sinus, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, ring or band fracture, and leaflet perforation.</p> <p><b>Caution:</b> Federal law (United States) restricts these devices to sale by or on the order of a physician.</p> <p>For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use (IFU). If applicable, consult electronic IFUs (eIFUs) at www.medtronic.com/manuals. Note: eIFUs can be viewed using a current version of any major internet browser.</p> <p>UC202409164 EN</p>

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