Simplici-T® Annuloplasty System
Indications, Safety and Warnings
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.
Adverse Effects: 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, or damage to coronary arteries.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, and warnings, please refer to the Instructions for Use.
For further information, please call Medtronic at (877) 526-7890 or visit www.medtronic.com.
