Impella®
Impella®
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Therapies
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Impella®
The World's Smallest Heart Pump

Delivers up to 5.0 L/min of forward blood flow from the left ventricle

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Impella 5.0®
Impella LD®

Impella 5.0®

How It Works:

 The Impella 5.0 heart pump is an intravascular microaxial blood pump that delivers up to 5.0 L/min of forward flow blood from the left ventricle to the aorta.

Insertion:

 The Impella 5.0 can be inserted into the left ventricle via femoral cut down or through the axillary artery, and goes through the ascending aorta, across the valve and into the left ventricle.

Impella LD®

How It Works:

 The Impella LD heart pump is a minimally invasive, catheter-based cardiac assist device designed to directly unload the left ventricle, reduce myocardial workload and oxygen consumption while increasing cardiac output, coronary and end- organ perfusion. The Impella LD can be inserted into the left ventricle via open chest procedures. The Impella LD pump is inserted through the ascending aorta, across the valve and into the left ventricle.

Insertion:

 The Impella LD can be inserted into the left ventricle via open chest procedures, by way of the ascending aorta, across the valve and into the left ventricle.

Estimating Impella 5.0™/Impella LD™ Flow from Motor Current

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Indications For Use

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.

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 the use of Impella in this indication.  Visit www.cardiogenicshock.com/isi to learn more.

Contraindications and Warnings

The Impella devices are contraindicated for use in this indication for patients experiencing 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 (with respect to the Impella 2.5)) or (graded as ≥ +2 equivalent to an orifice area of 1.5 cm2 or less (with respect to the Impella CP, Impella 5.0 and Impella LD)); 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; Ongoing CPR; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD); Left ventricular rupture; and Cardiac tamponade.