Profile 3D™ Annuloplasty System

Indications, contraindications, warnings, precautions, and adverse events

INDICATIONS

This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

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.

Profile 3D is a trademark of Medtronic, Inc.