INDICATIONS, SAFETY, AND WARNINGS Contour 3D™ Annuloplasty Ring

Indications

The Contour 3D ring is indicated for the reconstruction and/or remodeling of pathological tricuspid 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, right ventricular outflow tract obstruction, anticoagulant-related bleeding, or hemorrhage.

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.

Contact Information

LifeLine Cardiovascular Technical Support

877-526-7890

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