Duran AnCore

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. 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.