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Indications, Safety, and WarningsIndicationsThe SimuPlus™ flexible annuloplasty ring and band are indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimuPlus™ flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) and restrict expansion of the annulus.ContraindicationsSevere, generalized, or localized bacterial endocarditis, heavily calcified valves, greatly dilated annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), valvular retraction with severely reduced mobility, congenital malformations with lack of valvular tissue.Warnings, precautions, and adverse eventsOnly surgeons who have received appropriate training in valve repair, including ring implant and sizing techniques, 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, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, ring or band fracture, leaflet perforation, bleeding diathesis.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician. For a list of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use. For countries that use electronic instructions for use, consult instructions for use.

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