Impella®
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Impella®
The World's Smallest Heart Pump

Delivers peak flows >6 L/min of full forward flow from the left ventricle

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Impella 5.5 with SmartAssist®

How It Works:

 The Impella 5.5 with SmartAssist is a minimally invasive, forward flow, fully unloading heart pump designed for surgical use, delivering peak flows of >6 L/min, allowing the heart to rest; enabling heart recovery. This next generation heart pump is designed to improve patient outcomes by using real-time intelligence to optimize positioning, managing and weaning of the Impella device for better patient care. The Impella 5.5 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. New hemodynamic sensor technology allows for repositioning in the ICU without the need for imaging*; the optical sensor senses aortic pressure while the micro-axial motor senses the blood flow (pressure) between the aorta and the left ventricle. *For ventricularized pumps

Insertion:

 The Impella 5.5 with SmartAssist can be inserted through the axillary artery or anterior aorta and across the valve and into the left ventricle.

Impella 5.5 with SmartAssist is safe and effective for use during treatment of patients in cardiogenic shock.

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Automated Impella® Controller

How It Works:

 

The Automated Impella® Controller is the primary user control interface for the Impella® platform featuring a 10-inch high-resolution display. It controls the Impella catheter performance, monitors for alarms, and displays real-time hemodynamic and catheter position information.

The new integrated purge system automatically sets the purge flow to maintain the purge pressure and eliminates the need to actively monitor purge pressures. Step-by-step on-screen procedures allow for quick and simple step-up and purge cassette procedures; featuring automatic priming, detection of connections, and automatic bolus at completion.

The Automated Impella Controller can be powered by AC power or can operate on internal battery power for at least 60 minutes when fully charged.

Indications For Use

Cardiogenic Shock
The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0®, Impella 5.5™ with SmartAssist® 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, Impella CP, and the Impella CP with SmartAssist, and ≤ 14 days for the Impella 5.0, Impella 5.5 with SmartAssist 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 or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis 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.

Contraindications and Warnings

The Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist 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.abiomed.com/important-safety-information to learn more.