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Impella®
The World's Smallest Heart Pump

Percutaneous insertion and increased flow

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Impella CP®

How It Works:

 The Impella CP® heart pump pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta. The increased flow of the Impella CP is delivered on the same platform as the Impella 2.5™.

Insertion:

 The Impella CP device can be inserted via a standard catheterization procedure through the femoral artery, into the ascending aorta, across the valve and into the left ventricle.

Impella CP® heart pump is safe and effective for use during high-risk PCI procedures and for patients in cardiogenic shock.

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Indications for Use

Protected PCI
The Impella 2.5™ and Impella CP® Systems are 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 and Impella CP Systems are indicated for short term use (≤ 4 days) 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 treatment with Impella 2.5 and Impella CP is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

 

CARDIOGENIC SHOCK
The Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ catheters, in conjunction with the Automated Impella Controller, 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 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.*  The intent of the 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.

 

* Optimal medical management and convention treatment measures include volume loading and use of pressors and inotropes, with or without IABP.

 

Contraindications and Warnings

The Impella 2.5 and Impella CP 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 2.5 and Impella CP Systems; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Sepal 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, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Renal failure, Thrombocytopenia and Vascular injury

The institution of circulatory support using Impella has not been studied in the following conditions:  presence of irreversible end-organ failure; and presence of severe anoxic brain injury

 

 

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella 2.5 and Impella CP. Visit www.protectedpci.com/information/isi and www.cardiogenicshock.com/information/isi to learn more.