Healthcare Professionals
Indications, Safety, and Warnings
Indications
The Simulus® Semi-Rigid Mitral Annuloplasty Ring and Band are for use in those patients undergoing surgery of diseased or damaged mitral 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 natural annulus and restrict expansion of the annulus.
Contraindications
- Severe, generalized or localized bacterial endocarditis
- Heavily calcified valves
- Greatly dilated annulus (not reducible by standard techniques)
- Severe valvular dysfunction (not correctable by standard techniques)
- Valvular retraction with severely 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.