INDICATIONS, SAFETY, AND WARNINGS Simulus Semi-Rigid Annuloplasty Ring and Band

Indications: The Simulus semi-rigid annuloplasty ring and band are for use in patients undergoing surgery for diseased or damaged mitral valves. The Simulus semi-rigid annuloplasty ring and band provide support for 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.

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 Note: Manuals can be viewed using a current version of any major internet browser.