Tri-Ad™

Indications, Safety, and Warnings

Indications

Tri-Ad Semi-Flexible Tricuspid Annuloplasty Rings are for use in patients undergoing surgery for diseased or damaged tricuspid valves. The Tri-Ad Semi-Flexible Tricuspid Annuloplasty Ring provides support for and restricts expansion of the annulus.

Contraindications

1. Severe, generalized or localized bacterial endocarditis
2. Heavily calcified valves
3. Greatly dilated annuls (not reducible by standard techniques)
4. Severe valvular dysfunction (not correctable by standard techniques)
5. Valvular retraction with severly reduced mobility
6. Congenital malformations with lack of valvular tissue

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.