Left Heart Support

Impella CP® with SmartAssist®

Impella CP® with SmartAssist®

The Impella (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for the following indications, as well as others:

  • The Impella heart pump is a circulatory support system for patients with reduced left ventricular function, e.g. post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction
  • The Impella heart pump may also be used be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome
  • Support during high-risk percutaneous coronary intervention (PCI)
  • Post-PCI
  • Mechanical aortic valves, severe aortic valvular stenosis or valvular regurgitation
  • Hematological disorder causing fragility of the blood cells or hemolysis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Aneurysm or necrotomy or severe anomaly of the ascending aorta and/or the aortic arch
  • Mural thrombus in the left ventricle
  • Ventricular septal defect (VSD) after myocardial infarction
  • Anatomic conditions precluding insertion of the pump
  • Other illnesses or therapy requirements precluding use of the pump
  • Severe peripheral arterial occlusion disease (PAOD) is a relative contraindication

There are risks of complications with every procedure using a blood pump.

These include among other:

  • Hemolysis
  • Bleeding
  • Immune reaction
  • Embolism, thrombosis
  • Vascular injury through to angionecrotomy
  • Positioning problems
  • Infection and septicemia
  • Dislocation of the pump
  • Cardiovalvular injuries due to extreme movement of the suction cannula in relation to the cardiac valve or as a result of attachment by suction of the pump to the valve system following incorrect positioning
  • Endocardiac injuries as a result of attachment of the pump due to suction
  • Pump failure, loss of pump components following a defect
  • Patient dependency on the pump after use for support

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. For more information please see the Instructions for Use Manuals.

Precautions

  • The pump performance metrics derived from the Impella pump signals are not valid for monitoring the overall clinical status of the patient and should be used for informational purposes only
  • The pump performance metrics derived from the Impella pump signals are not intended for diagnostic use. All parameters displayed must be verified independently using either a cleared or approved diagnostic device, and must not be used for patient monitoring

Impella CP®
& Impella 2.5®

Impella CP® & Impella 2.5®

The Impella (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 5 days for the following indications, as well as others:

  • The Impella heart pump is a circulatory support system for patients with reduced left ventricular function, e.g. post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction
  • The Impella heart pump may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome
  • Support during high risk percutaneous coronary intervention (PCI)
  • Post-PCI
  • Mechanical aortic valves, severe aortic valvular stenosis or valvular regurgitation
  • Hematological disorder causing fragility of the blood cells or hemolysis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Aneurysm or necrotomy or severe anomaly of the ascending aorta and/or the aortic arch
  • Mural thrombus in the left ventricle
  • Ventricular septal defect (VSD) after myocardial infarction
  • Anatomic conditions precluding insertion of the pump
  • Other illnesses or therapy requirements precluding use of the pump
  • Severe peripheral arterial occlusion disease (PAOD) is a relative contraindication

There are risks of complications with every procedure using a blood pump. These include:

  • Hemolysis
  • Bleeding
  • Immune reaction
  • Embolism, thrombosis
  • Vascular injury through to angionecrotomy
  • Positioning problems
  • Infection and septicemia
  • Dislocation of the pump
  • Cardiovalvular injuries due to extreme movement of the suction cannula in relation to the cardiac valve or as a result of attachment by suction of the pump to the valve system following incorrect positioning
  • Endocardiac injuries as a result of attachment of the pump due to suction
  • Pump failure, loss of pump components following a defect
  • Patient dependency on the pump after use for support

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. For more information please see the Instructions for Use Manuals.

Impella 5.0®
& Impella LD®

Impella 5.0® & Impella LD®

Impella 5.0®, Impella LD®: The Impella (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 10 days for the following indications, as well as others:

  • The Impella heart pump is a cardiovascular support system for patients with reduced left ventricular function, eg, post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction
  • The Impella heart pump may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with high risk of postoperative low output syndrome
  • Mechanical aortic valves, severe aortic valvular stenosis or valvular regurgitation
  • Hematological disorder causing fragility of the blood cells or hemolysis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Aneurysm or necrotomy or severe anomaly of the ascending aorta and/or the aortic arch
  • Mural thrombus in the left ventricle
  • Ventricular septal defect (VSD) after myocardial infarction
  • Anatomic conditions precluding insertion of the pump
  • Other illness or therapy requirements precluding use of the pump
  • Severe peripheral arterial occlusion disease (PAOD) is a relative contraindication

There are risks of complications with every procedure using blood pump. These include among others:

  • Hemolysis
  • Bleeding
  • Immune reaction
  • Embolism, thrombosis
  • Vascular injury through to angionecrotomy
  • Positioning problems
  • Infection and septicemia
  • Dislocation of the pump
  • Cardiovalvular injuries due to extreme movement of the suction cannula in relation to the cardiac valve or as a result of attachment by suction of the pump to the valve system following incorrect positioning
  • Endocardiac injuries as a result of attachment of the pump due to suction
  • Pump failure, loss of pump components following a defect
  • Patient dependency on the pump after use for support

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. For more information please see the Instructions for Use Manual.

Impella 5.5® with SmartAssist®

Impella 5.5® with SmartAsisst®

The Impella 5.5 with SmartAssist heart pump is an intracardiac pump for supporting the left ventricle. It is intended for clinical use in cardiology and in cardiac surgery for up to 30 days for the following indications, as well as others:

  • The Impella 5.5 with SmartAssist heart pump is a cardiovascular support system for patients with reduced left ventricular function, e.g. post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction
  • The Impella 5.5 with SmartAssist heart pump may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome

The Impella 5.5 with SmartAssist heart pump is contraindicated for the following situations:

  • Mechanical aortic valves, severe aortic valvular stenosis
  • Hematological disorder causing fragility of the blood cells or hemolysis
  • Hypertrophic obstructive cardiomyopathy (HOCM)
  • Aneurysm or necrotomy or severe anomaly of the ascending aorta and/or the aortic arch
  • Mural thrombus in the left ventricle
  • Ventricular septal defect (VSD) after myocardial infarction
  • Anatomic conditions precluding insertion of the pump

There are risks of complications with every procedure using a blood pump. These include among other:

  • Hemolysis
  • Bleeding
  • Immune reaction
  • Embolism, Thrombosis
  • Vascular injury through to angionecrotomy
  • Positioning problems
  • Infection and septicemia
  • Dislocation of the pump
  • Cardiovalvular injuries due to extreme movement of the suction cannula in relation to the cardiac valve or as a result of attachment by suction of the pump to the valve system following incorrect positioning
  • Endocardiac injuries as a result of attachment of the pump due to suction
  • Pump failure, loss of pump components following a defect
  • Patient dependency on the pump after use for support

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. For more information please see the Instructions for Use Manuals.


Right Heart Support

Impella RP®

Impella RP

The Impella RP System (percutaneous pump for right ventricular support) is intended for clinical use in cardiology, in cardiac surgery, and intensive care for up to 14 days for the following indications, as well as others:

  • Acute or transient reduction of the right ventricular function (eg, postcardiotomy low output syndrome)
  • Cardiogenic shock as a consequence of a posterior myocardial infarction with right ventricular heart failure
  • Right heart support during coronary beating heart bypass surgery, especially for patients with a reduced preoperative cardiac output or for patients having a high risk of developing a postoperative low output syndrome for other reasons
  • Right ventricular heart failure after implantation of a left ventricular assist device
  • Therapy unresponsive arrythmias with a reduction of right ventricular output
  • Heart failure and/or cardiogenic shock as a consequence of refractory ventricular arrythmias, as well as a consequence of sustained supraventricular arrythmias, causing haemodynamic compromise
  • Arteriosclerosis, in particular calcification or other disorders of the pulmonary artery wall
  • Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid valve or pulmonary valve
  • Mural thrombus of the right atrium or vena cava
  • Anatomic conditions precluding insertion of the pump
  • Other illness or therapy requirements precluding the use of the pump
  • Presence of a vena caval filter interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter

There are risks of complications with every procedure using a blood pump. These include among other:

  • Hemolysis
  • Bleeding
  • Immune reaction
  • Embolism
  • Thrombosis
  • Vascular injury through angionecrotomy
  • Infection and septicemia
  • Endocardiac injuries due to attachment by suction of the pump to the inferior vena cava
  • Pump failure, loss of pump components following a defect
  • Patient dependency on the pump after use for support

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. For more information please see the Instructions for Use Manuals.