Illustration of a heart on the navy background with hash pattern overlay

Impella 5.5®

with SmartAssist®
A heart pump designed for surgeons with forward flow and intelligent patient management

Overview

Impella 5.5 with SmartAssist delivers full cardiac support with maximum unloading, allowing the heart to rest and recover.

It is a microaxial, surgically implanted heart pump that unloads the left ventricle, reduces ventricular work, and provides the circulatory support necessary to allow recovery and early assessment of residual myocardial function. It is designed for long-duration support and enables ambulation to optimize recovery while using real-time SmartAssist intelligence.

Clinical Evidence

A study published in the journal ASAIO examined the outcomes of the first 55 patients treated with Impella 5.5 with SmartAssist at Cleveland Clinic, Hackensack University Medical Center/Hackensack Meridian Health and Cedars-Sinai Medical Center. Study authors and cardiac surgeons Ed Soltesz, MD, Mark Anderson, MD, and Danny Ramzy, MD, conclude Impella 5.5 with SmartAssist is clinically appropriate for a number of challenging scenarios, including AMI cardiogenic shock.1

  • 84%

    Survival rate1

  • 76%

    Survivors recovered native heart function1

 

Danny Ramzy, MD, discusses his experience with the Impella 5.5 with SmartAssist heart pump and the importance of the Impella Connect

Accessories

Image of the Impella 5.5 Kit
Image of Automated Impella Controller™
Image of Axillary Insertion Kit
Image of 0.018” x 260 cm Placement Guidewire
Image of Purge Cassette

Additional Resources

Impella 5.5 with SmartAssist for use during cardiogenic shock

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Learn more about the SmartAssist platform, new features, the Automated Impella Controller and specifications.

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Learn more about the features of the Impella 5.5 with SmartAssist heart pump.

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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.

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.

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.

Footnotes

  1. Ramzy, D., et al. (2020). New Surgical Circulatory Support System Outcomes. ASAIO Journal. 

IMP-1703