CG Future™ annuloplasty system
The CG Future™ ring or band is used to repair your heart’s natural mitral valve when it has become diseased or weakened by age.
The CG Future™ ring or band should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).
Mitral valve repair procedures may include, but are not limited to the following risks:
- Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
- Damage to red blood cells (hemolysis)
- Any problem with the band or ring that causes narrowing of the valve opening (stenosis)
- Small amounts of blood leaking through the valve opening even after it closes (regurgitation)
- Abnormal heart beat (dysrhythmia)
- Inflammation of the lining of the heart (endocarditis)
- Anticoagulant-related bleeding or hemorrhage
This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Contour 3D™ annuloplasty ring
The Contour 3D™ annuloplasty ring is used to repair your heart’s natural tricuspid valve when it has become diseased or weakened by age.
The Contour 3D™ annuloplasty ring should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).
Tricuspid valve repair procedures may include, but are not limited to the following risks:
- Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
- Damage to red blood cells (hemolysis)
- Any damage with the band or ring that causes narrowing of the valve opening (stenosis)
- Small amounts of blood leaking through the valve opening even after it closes (regurgitation)
- Abnormal heart beat (dysrhythmia)
- Inflammation of the lining of the heart (endocarditis)
- Anticoagulant-related bleeding or hemorrhage
- Damage to the heart’s conduction system
This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Duran AnCore™ annuloplasty system
The Duran AnCore™ annuloplasty ring or band is used to repair your heart’s natural mitral or tricuspid valve when it has become diseased or weakened by age.
The Duran AnCore™ system should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).
Valve repair procedures may include, but are not limited to the following risks:
- Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
- Damage to red blood cells (hemolysis)
- Any problem with the band or ring that causes narrowing of the valve opening (stenosis)
- Small amounts of blood leaking through the valve opening even after it closes (regurgitation)
- Abnormal heart beat (dysrhythmia)
- Inflammation of the lining of the heart (endocarditis)
- Anticoagulant-related bleeding or hemorrhage
This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Profile 3D™ annuloplasty system
The Profile 3D™ ring may be used to repair your heart’s natural mitral valve when it has become diseased or weakened by age.
The Profile 3D™ ring should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, and active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria).
Mitral valve repair procedures may include, but are not limited to the following risks:
- Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
- Damage to red blood cells (hemolysis)
- Any problem with the ring that causes narrowing of the valve opening (stenosis)
- Small amounts of blood leaking through the valve opening even after it closes (regurgitation)
- Abnormal heart beat (dysrhythmia)
- Inflammation of the lining of the heart (endocarditis)
- Anticoagulant-related bleeding or hemorrhage
This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
SimuForm™ semi-rigid annuloplasty ring
The SimuForm™ semi-rigid annuloplasty ring is used to repair your heart’s natural mitral valve when it has become diseased or weakened by age.
The SimuForm™ semi-rigid ring should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria), greatly dilated annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), and congenital malformations with lack of valvular tissue.
Mitral valve repair procedures may include, but are not limited to the following risks:
- Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
- Damage to red blood cells (hemolysis)
- Any damage with the band or ring that causes narrowing of the valve opening (stenosis)
- Small amounts of blood leaking through the valve opening even after it closes (regurgitation)
- Abnormal heart beat (dysrhythmia)
- Inflammation of the lining of the heart (endocarditis)
- Anticoagulant-related bleeding or hemorrhage
This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
SimuPlus™ flexible annuloplasty ring and band
The SimuPlus™ flexible annuloplasty ring and band are used to repair your heart’s natural mitral or tricuspid (band only) valve when it has become diseased or weakened by age.
The SimuPlus™ flexible annuloplasty ring and band should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria), greatly dilated annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), and congenital malformations with lack of valvular tissue.
Valve repair procedures may include, but are not limited to the following risks:
- Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
- Damage to red blood cells (hemolysis)
- Any damage with the band or ring that causes narrowing of the valve opening (stenosis)
- Small amounts of blood leaking through the valve opening even after it closes (regurgitation)
- Abnormal heart beat (dysrhythmia)
- Inflammation of the lining of the heart (endocarditis)
- Anticoagulant-related bleeding or hemorrhage
- Damage to the heart’s conduction system
This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Tri-Ad 2.0™ Adams tricuspid annuloplasty band
The Tri-Ad 2.0™ Adams tricuspid annuloplasty band is used to repair your heart’s natural tricuspid valve when it has become diseased or weakened by age.
The Tri-Ad 2.0™ Adams tricuspid annuloplasty band should not be used in patients with heavily calcified valves, valvular retraction with severely reduced mobility, active bacterial endocarditis (inflammation of the lining of the heart caused by bacteria), greatly dilated annulus (not reducible by standard techniques), severe valvular dysfunction (not correctable by standard techniques), and congenital malformations with lack of valvular tissue.
Tricuspid valve repair procedures may include, but are not limited to the following risks:
- Blood clot formation on or around the valve. These blood clots may break loose and travel in the bloodstream (thromboembolism/thrombosis)
- Damage to red blood cells (hemolysis)
- Any damage with the band or ring that causes narrowing of the valve opening (stenosis)
- Small amounts of blood leaking through the valve opening even after it closes (regurgitation)
- Abnormal heart beat (dysrhythmia)
- Inflammation of the lining of the heart (endocarditis)
- Anticoagulant-related bleeding or hemorrhage
- Damage to the heart’s conduction system
This list is not inclusive of all risks. Talk to your physician regarding more information about valve repair surgery.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.