Indications, Safety, and Warnings Heart Valve Repair — Surgical

CG Future Annuloplasty System

Indications:  The CG Future annuloplasty ring and CG Future annuloplasty band are indicated for the reconstruction or remodeling of pathological mitral valves. Valvular insufficiency or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

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.

Contour 3D Tricuspid Annuloplasty Ring

Indications: The Contour 3D ring is indicated for the reconstruction and/or remodeling of pathological tricuspid valves.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

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, right 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 medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.

Profile 3D Annuloplasty System

Indications: This device is indicated for the reconstruction and/or remodeling of pathological mitral valves. Valvular insufficiency and/or stenosis may be corrected by appropriate repair and annular remodeling.

Contraindications: Heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis.

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.

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.

SimuPlus Flexible Annuloplasty Ring and Band

Indications: The SimuPlus flexible annuloplasty ring and band are indicated for use in patients undergoing surgery for diseased or damaged mitral valves. The band is indicated for the same use for tricuspid valves. The SimuPlus flexible annuloplasty ring and band provide support for the mitral annulus or tricuspid annulus (band only) 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 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 or band 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 or band fracture, leaflet perforation, bleeding diathesis.

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

Tri-Ad 2.0 Adams Tricuspid Annuloplasty Ring

Indications: The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support and restricts expansion of the tricuspid 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, 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 medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.