INDICATIONS, SAFETY, AND WARNINGS SimuForm™ Annuloplasty Ring

Indications

The SimuForm semi-rigid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged mitral valves. The SimuForm semi-rigid annuloplasty ring provides support for the mitral annulus and restricts 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 surgeons who have received appropriate training in valve repair, including ring implant and sizing techniques, should use this device. Adverse events can include: uncorrected or recurrent regurgitation, stenosis, ring dehiscence, hemolysis (even with mild regurgitation), low cardiac output, heart block, systolic anterior motion (SAM) and left ventricular outflow tract obstruction (LVOTO), damage to coronary arteries, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, ring fracture, leaflet perforation, bleeding diathesis.

Caution

Federal law (USA) restricts this device to sale by or on the order of a physician.

For a complete listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use.

Contact Information

LifeLine Cardiovascular Technical Support

877-526-7890

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