INDICATIONS, SAFETY, AND WARNINGS Simplici-T Annuloplasty System
Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis.
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, band dehiscence, hemolysis, stenosis, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage, uncorrected or recurrent regurgitation, low cardiac output, thrombosis, damage to coronary arteries.
Caution: 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 www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.