Important Safety Information for the Impella® Heart Pump
This information is being provided to you for educational purposes. Individual experiences, symptoms, and results may vary. Please consult your physician to discuss your condition and appropriate medical treatment.
How is the Impella 2.5™ and Impella CP® Device Used?
The Impella 2.5™ and Impella CP®, the World’s Smallest Heart Pumps, and are intended for temporary (less than six hours) use to maintain stable heart function. The Impella 2.5™ and Impella CP® can potentially lower certain risks in patients with severe coronary artery disease and diminished (but stable) heart function who are undergoing a percutaneous coronary intervention (PCI) such as an angioplasty or stenting, but are not candidates for surgery, as determined by a team of doctors that includes a heart surgeon.
Important Risk Information for the Impella 2.5 and Impella CP Devices
Protected PCI is not right for everyone. You should NOT be treated with the Impella 2.5 or Impella CP if your doctor determines you have certain pre-existing conditions, such as: Severe narrowing of your heart valves; Clots in your blood vessels; Replacement heart valve or; Certain deficiencies in your heart valve. Many of the risks related to the Impella 2.5 and Impella CP devices are the same as those with the procedure being completed and the placement of any pump used to help the heart. Risks related to use of the Impella 2.5 and Impella CP can include certain allergic reactions to medications, infections, blood clots, injury to heart tissue, valves or blood vessels, bleeding, low blood pressure, low platelet count and/or damage to red blood cells. Some of these conditions could be life threatening. To learn more about additional risk information associated with the use of the Impella 2.5 and Impella CP, speak with your doctor.
Cardiogenic Shock with the Impella 2.5™, Impella CP®, Impella 5.0™, and Impella LD™ heart pumps Impella 2.5™, Impella CP®, Impella 5.0™, and Impella LD™
IMPORTANT SAFETY INFORMATION FOR THE IMPELLA® SYSTEM THERAPY
How is the Impella® System Used? The Impella® Heart Pumps (Impella 2.5™, Impella CP®, Impella 5.0™, and Impella LD™, in conjunction with the Automated Impella® Controller ) may help patients who need emergency support of the left heart as a result of a condition known as Cardiogenic Shock. Use of the Impella System in such situations assists the pumping function of the heart and may provide the circulatory support necessary to allow heart recovery.
Typical patients who may benefit from the Impella® System Therapy include:
• Patients whose left heart fails because of a heart attack
• Patients whose left heart fails during heart surgery
The Impella® System Therapy must be used in a hospital. Patients who receive Impella® System Therapy must remain in the hospital until the Impella device is removed.
Important Risk Information for Impella® System Therapy
THE IMPELLA® SYSTEM THERAPY IS NOT RIGHT FOR EVERYONE.
You should NOT be treated with Impella® System Therapy if your doctor determines you have certain pre-existing conditions, such as:
• Loosely attached clots in your left ventricle;
• A replacement heart valve or other heart device;
• Severe narrowing of a heart valve;
• A problem with your heart valve that allows blood to leak back into the left ventricle from the aorta;
• Defects in your veins and arteries that could block the pump;
• A severe problem with your right ventricle;
• A severe problem with your lungs that prevents them from providing oxygen to your blood;
• If CPR is being administered;
• A defect in your heart that could shunt the blood flow and reduce the pump output;
• A split or rupture of the left ventricle; or
• A build-up of blood in the space around your heart.
All cardiac procedures have risks. Many of the risks with the Impella® System Therapy are the same as those with the placement of any pump used to help the heart.
Insertion and use of Impella® System Therapy may result death or the following life-threatening conditions:
• A bleeding event, which can require blood to be put back into your body (transfusion)
• Damage to your blood cells, which may be caused by the Impella blood pump or other pumps used during surgery
• Stroke, which is a condition when decreased blood flow to the brain causes death of brain cells
• Reduced blood flow to your leg, where the Impella blood pump is inserted
• Allergic reaction to medication, for instance a blood thinner called heparin, which is used in conjunction with the Impella® blood pump device
• Blood clots may develop, which can travel through your blood vessels and block the blood flow to other organs, including your lungs making breathing difficult
• The development of an infection, which could be localized or spread throughout your body
• Heart tissues may be irritated or injured by the device as it is placed into the heart or during the time it sits inside the heart
• Kidneys, Liver, may not receive enough blood to function efficiently and may not function normally
To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.cardiogenicshock.com/information/isi