Tricuspid Repair Disclaimer
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Repair valve
Mitral
Tricuspid
Replace aortic valve
Pericardial
Porcine
Transcatheter
Heart Valve
Replace mitral valve
Pericardial
Porcine

Edwards Lifesciences Heart Valve Therapy Disclaimer


This therapy is not for everyone.  Please consult your physician.  A prescription is required.  Careful and continuous medical follow-up is required so that device-related complications can be diagnosed and properly managed to minimize danger to the patient.

Edwards MC3 tricuspid annuloplasty ring
The Edwards MC3 tricuspid annuloplasty ring is used in patients to correct annular dilatation (when the size of the heart valve becomes enlarged), to increase coaptation of the valve leaflets (by providing support to the leaflet tissue, the ring helps them close properly as the heart beats), and to prevent further increases in annular dilatation in the tricuspid valve.  The ring is implanted directly above the tricuspid valve using sutures.

Valve repair can include the following risks:
  • The valve continues to leak (residual valvular insufficiency) or it develops new leaks (recurrent valvular insufficiency).
  • The valve does not open properly.
  • Clots from the device break off and enter the bloodstream (thromboembolism).
  • Damage to red blood cells that can result in anemia (hemolysis).
  • The conduction system (how the heart controls its beating) is damaged.
  • Low cardiac output (the heart does not pump enough blood).
  • Right heart failure.
  • Failure or degeneration of the patient’s natural valvular apparatus due to progression of the disease, endocarditis (infection of the heart), or inadequate or incomplete repair of the valve or other parts of the heart that affect the valve.
  • Damage to coronary artery (provides blood to the cells of the heart) due to suture placement.
  • Complications related to prolonged time on cardio-pulmonary bypass (during surgery the heart is stopped and a machine takes over for your lungs and heart).
  • A suture(s) may come loose causing the ring to partially separate from the valve.
  • Malfunction of the ring due to distortion at implant or chemical deterioration of the ring components.
  • Tearing of the cloth covering the ring with the use of cutting needles.
  • Bleeding related to the use of anticoagulation therapy (blood thinners).
  • The blood flow of the heart is interrupted or partially blocked due to the size of the leaflets (tissue in the heart valves).
  • Localized or systemic (goes beyond the heart) infection.
CAUTION:  Federal law (USA) restricts this device to sale by or on the order of a physician.


Carpentier-Edwards Classic tricuspid annuloplasty ring
The Carpentier-Edwards Classic tricuspid annuloplasty ring is used in patients to correct annular dilatation (when the size of the heart valve becomes enlarged), to increase coaptation of the valve leaflets (by providing support to the leaflet tissue, the ring helps them close properly as the heart beats), and to prevent further increases in annular dilatation in the tricuspid valve.  The ring is implanted directly above the tricuspid valve using sutures.

Valve repair can include the following risks:
  • The valve continues to leak (residual valvular insufficiency) or it develops new leaks (recurrent valvular insufficiency).
  • The valve does not open properly.
  • Clots from the device break off and enter the bloodstream (thromboembolism).
  • Damage to red blood cells that can result in anemia (hemolysis).
  • The conduction system (how the heart controls its beating) is damaged.
  • Low cardiac output (the heart does not pump enough blood).
  • Right heart failure.
  • Failure or degeneration of the patient’s natural valvular apparatus due to progression of the disease, endocarditis (infection of the heart), or inadequate or incomplete repair of the valve or other parts of the heart that affect the valve.
  • Damage to coronary artery (provides blood to the cells of the heart) due to suture placement.
  • Complications related to prolonged time on cardio-pulmonary bypass (during surgery the heart is stopped and a machine takes over for your lungs and heart).
  • A suture(s) may come loose causing the ring to partially separate from the valve.
  • Malfunction of the ring due to distortion at implant or chemical deterioration of the ring components.
  • Tearing of the cloth covering the ring with the use of cutting needles.
  • Bleeding related to the use of anticoagulation therapy (blood thinners).
  • The blood flow of the heart is interrupted or partially blocked due to the size of the leaflets (tissue in the heart valves).
  • Localized or systemic (goes beyond the heart) infection.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.


Cosgrove-Edwards mitral and tricuspid annuloplasty ring
The Cosgrove-Edwards annuloplasty ring is used in patients to correct annular dilatation (when the size of the heart valve becomes enlarged), to increase coaptation of the valve leaflets (by providing support to the leaflet tissue, the ring helps them close properly as the heart beats), and to prevent further increases in annular dilatation in the mitral or tricuspid valve.  The ring is implanted directly above the mitral or tricuspid valve using sutures.

Valve repair can include the following risks:
  • The valve continues to leak (residual valvular insufficiency) or it develops new leaks (recurrent valvular insufficiency).
  • The valve does not open properly.
  • Clots from the device break off and enter the bloodstream (thromboembolism).
  • Damage to red blood cells that can result in anemia (hemolysis).
  • The conduction system (how the heart controls its beating) is damaged.
  • Low cardiac output (the heart does not pump enough blood).
  • Right heart failure.
  • Failure or degeneration of the patient’s natural valvular apparatus due to progression of the disease, endocarditis (infection of the heart), or inadequate or incomplete repair of the valve or other parts of the heart that affect the valve.
  • Damage to coronary artery (provides blood to the cells of the heart) due to suture placement.
  • Complications related to prolonged time on cardio-pulmonary bypass (during surgery the heart is stopped and a machine takes over for your lungs and heart).
  • A suture(s) may come loose causing the ring to partially separate from the valve.
  • Malfunction of the ring due to distortion at implant or chemical deterioration of the ring components.
  • Tearing of the cloth covering the ring with the use of cutting needles.
  • Bleeding related to the use of anticoagulation therapy (blood thinners).
  • The blood flow of the heart is interrupted or partially blocked due to the size of the leaflets (tissue in the heart valves).
  • Localized or systemic (goes beyond the heart) infection.
CAUTION:  Federal law (USA) restricts this device to sale by or on the order of a physician

 
 
This information is not a substitute for talking with your doctor.