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 medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.