Impella®
Impella®
Disease States
Therapies
Resources

Impella®
The World's Smallest Heart Pump

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

Play Full Video
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

Learn More


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 set-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.

 

Emergency Use Authorization

Impella Left Ventricular (LV) Support Systems (Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist) are authorized for emergency use by HCPs in the hospital setting for providing temporary (≤ 4 days for Impella 2.5, Impella CP, and Impella CP with SmartAssist; and ≤ 14 days for Impella 5.0 and Impella 5.5 with SmartAssist) LV unloading and support to treat critical care patients (i.e. patients in the intensive care unit) with confirmed COVID-19 infection who are undergoing ECMO treatment and who develop pulmonary edema while on V-A ECMO support or late cardiac decompensation from myocarditis while on V-V ECMO support. The Impella LV Support Systems have neither been cleared or approved for the authorized indication for use. The Impella LV Support Systems have been authorized for the above emergency use by the FDA under an EUA. The Impella LV Support Systems have been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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/impella and to learn more.

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 0.6cm2 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.