Important Safety Information

Indications for Use

Protected PCI


How the Impella Heart Pump Device is 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 and visit https://www.protectedpci.com/patient/information/isi

Cardiogenic Shock


How the Impella Heart Pump Device is 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:

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 the Impella® System Therapy


Protected PCI is not right for everyone.


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:

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:

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

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.


INDICATIONS FOR USE


The Impella 2.5® and Impella CP® Systems are a temporary (≤ 6 hours) ventricular support devices indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

The Impella 2.5®, Impella CP®, Impella 5.0®, and Impella LD® Catheters, in conjunction with the Automated Impella Controller (collectively, “Impella® System Therapy”), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function. IMPORTANT RISK INFORMATION FOR

IMPELLA DEVICES:


CONTRAINDICATIONS


The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*

* This condition is a contraindication for the cardiogenic shock indication only.

POTENTIAL ADVERSE EVENTS


Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices.

Visit www.protectedpci.com/hcp/information/isi and www.cardiogenicshock.com/hcp/information/isi to learn more.

INDICATIONS FOR USE

The Impella RP® is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area ≥ 1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Important Risk Information for Impella RP:

CONTRAINDICATIONS


The Impella RP is contraindicated for use with patients experiencing any of the following conditions: Pulmonary artery wall disorders precluding placement or correct positioning of the Impella RP device; Anatomic conditions precluding insertion of the pump; Tricuspid or pulmonic valve abnormalities including: mechanical valves, severe stenosis or regurgitation; Mural thrombus of the right atrium or vena cava; Other illnesses or therapy requirements precluding use of the pump; Presence of a vena cava filter or caval 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.

POTENTIAL ADVERSE EVENTS


Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device Malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia. In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP. Visit www.abiomed.com/impella/impella-rp to learn more.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.