IMPORTANT SAFETY INFORMATION MITRAL/TRICUSPID VALVE REPAIR


Contour 3D 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 www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser. 


Tri-Ad Adams Tricuspid Ring

Indications: Tri-Ad  Adams tricuspid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged tricuspid valves. The Tri-Ad Adams tricuspid annuloplasty ring provides support for 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 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 www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser. 


DURAN ANCORE ANNULOPLASTY SYSTEM

The Duran AnCore annuloplasty ring or band is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty ring or band is a loop or band of material made of durable artificial materials.)

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.
  • 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.


CG FUTURE ANNULOPLASTY SYSTEM

The CG Future™ Ring or Band is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty band is made of durable artificial materials.)

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).

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.
  • 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 valve when it has become diseased or weakened by age. (An annuloplasty ring is made of durable artificial materials.)

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).

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.
  • 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.


SIMULUS FLEXIBLE ANNULOPLASTY SYSTEM

The Simulus™ flexible annuloplasty system is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty band is made of durable artificial materials.)

The Simulus flexible 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).

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.
  • 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.


SIMULUS SEMI-RIGID ANNULOPLASTY SYSTEM

The Simulus™ semi-rigid annuloplasty system is used to repair your heart's natural valve when it has become diseased or weakened by age. (An annuloplasty band is made of durable artificial materials.)

The Simulus semi-rigid 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).

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.
  • 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.