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
- Severe, generalized or localized bacterial endocarditis
- Heavily calcified valves
- Greatly dilated annuls (not reducible by standard techniques)
- Severe valvular dysfunction (not correctable by standard techniques)
- Valvular retraction with severly reduced mobility
- 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.