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

Impella 5.0® and Impella LD®

Heart pumps that deliver forward blood flow from the left ventricle

Overview

The Impella 5.0 and Impella LD heart pumps are intravascular, microaxial blood pumps that deliver up to 5.0 L/min of forward flow from the left ventricle to the aorta. These heart pumps are for heart teams who need full left ventricular unloading and full systemic flow for a patient.

Impella 5.0 is inserted through the axillary artery or femoral cut down. Benefits include:

  • Immediately ambulate patients
  • Resting the left ventricle has proven to increase heart recovery while keeping other therapeutic options open1,2
  • Integrated microaxial impeller pulls blood from the ventricle into the aorta

Impella LD can be an open-chested, direct support option with 5.0 L/m of flow, when post-cardiotomy cardiogenic shock (PCCS) is unanticipated and fluoroscopy is not available.

  • After the closing of the sternum, patients can be ambulated with Impella LD while resting their left ventricle1
  • Direct access aortic surgical placement

 

 

 

Clinical Evidence

RECOVER I was a prospective, single-arm, feasibility trial to investigate the safety and feasibility of Impella 5.0 in patients experiencing cardiogenic shock after cardiac surgery.1 Impella 5.0 was successfully placed in all of the 16 patients. Hemodynamic parameters improved immediately after device placement leading to an increase in mean cardiac index from 1.4 to 2.5 L/min/m2 and MAP from 71 mmHg to 83 mmHg. Hemodynamics improved in conjunction with a decreased need for inotropic medications.

  • 93%

    Native heart recovery of patients discharged after cardiogenic shock1

  • 75%

    Survival to one year1

 

Impella Support for COVID-19 Myocarditis

Amit Pawale, MD, presents the case of a 56-year-old male with COVID-19 myocarditis. He and his team used ECMO to oxygenate the patient and Impella 5.0 to unload the left ventricle.

Accessories

Image of the Impella 5.0 Kit
Image of the Impella LD Kit
Image of the Automated Impella Controller™
Image of the Axillary Insertion Kit
Image of the Purge Cassette
Image of the White Connector Cable

Additional Resources

Impella® ventricular support systems for use during cardiogenic shock and high-risk PCI

View PDF

Step-by-step guide to left heart unloading with the Impella 5.0 heart pump.

View PDF

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. Griffith, B.P., et al. (2013). J Thorac Cardiovasc Surg, 145(2), 548-554.
  2. Perme, C., et al. (2006). Texas Heart Institute Journal, 33, 130-133.

IMP-1702