Simulus Flexible Annuloplasty System

Indications, Safety, and Warnings

Indications

The Simulus^® Adjustable Annuloplasty Ring and Band are for use in those patients undergoing surgery of diseased or damaged mitral or tricuspid valves in whom the surgeon determines that the valve can be preserved by employing the appropriate surgical repair. The annuloplasty ring and band provide support for the mitral or tricuspid annulus and restrict expansion of the annulus.

Contraindications

1. Severe, generalized or localized bacterial endocarditis
2. Heavily calcified valves
3. Greatly dilated annulus (not reducible by standard techniques)
4. Severe valvular dysfunction (not correctable by standard techniques)
5. Valvular retraction with severely 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.