Indications
This device is indicated for the reconstruction or remodeling of pathological mitral and tricuspid valves. Appropriate repair and annular remodeling may correct combined valvular insufficiency and stenosis. Note: The Chordal Guide feature of the Duran AnCore Ring/Band with Chordal Guide is indicated only for chordal replacement surgery of pathological mitral valves.
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, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, systolic anterior motion, left ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.
For additional information please refer to the Instructions for Use provided with the product or contact your local Medtronic representative.
Caution
Federal law (USA) restricts this device to sale by or on the order of a physician.