Simulus Flexible Annuloplasty System

Summary

The Simulus Flexible Annuloplasty Ring and Band are made of flexible, braided polyester, allowing them to mimic natural valve dynamics. The ring and band maintain their shape when used on or off the holder, enabling manipulation in varied approaches and exposures.

The Simulus flexible ring and band feature:

• Flexibility without elasticity – discourages stretching, crimping, and bunching¹
• Low resistance – provides easy needle passage along the entire width of the ring
• Tungsten and barium sulfate core – provides radiographic visualization
• Trigone markers – assist in suture placement and ring/band positioning
• Nine sizes – ranging from 23 mm to 39 mm

A spoke-ring holder used during implant is made of clear polysulfone for visibility. It features a proprietary one-cut release and a malleable handle to help reach the valve annulus.

Important Safety Information

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 a complete listing of Indications, Contraindications, Warnings, Precautions and Adverse events, please refer to the Instructions for Use provided with the product.