Impella 2.5®

Smaller access for unloading the left ventricle

Overview

The Impella 2.5 heart pump is FDA-approved to provide hemodynamic stability during a Protected PCI procedure. It is also FDA-approved for the treatment of acute myocardial infarction (AMI) cardiogenic shock.

This left-sided device is delivered across the aortic valve, generating forward blood flow in the ascending aorta and directly unloading pressure and volume.    

  • Inserted percutaneously and unloads blood from the left ventricle into the ascending aorta
  • Maintains up to 2.5 L/min of blood flow during a procedure

Clinical Evidence

PROTECT II was a landmark prospective, multicenter, randomized controlled trial (RCT) of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump (IABP) in patients undergoing nonemergent high-risk percutaneous coronary intervention (PCI). The study was designed to assess whether an Impella-supported high-risk percutaneous revascularization strategy would result in better outcomes than a revascularization strategy with IABP support. It found patients treated with Impella had a 29% reduction in major adverse cardiovascular and cerebrovascular events (MACCE) at 90 days, compared to patients treated with IABP.1,2

  • 22%

    Risk reduction1

  • 53%

    Reduction in hypotensive events compared to IABP

 

Watch renowned interventional cardiologists discuss how Impella 2.5 maintains MAP during a PCI procedure and more complete revascularization

Accessories

Additional Resources

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

View PDF

For best outcomes in AMI cardiogenic shock, place Impella 2.5 or Impella CP® pre-PCI

View PDF

Indications for Use

High-Risk PCI

The Impella 2.5®, Impella CP® and Impella CP® with SmartAssist® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5, Impella CP, and Impella CP with SmartAssist Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

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. O’Neill, W.W., et al. (2012). Circulation, 126(14), 1717-1727.
  2. Dangas, G.D., et al. (2014). Am J Cardiol, 113(2), 222-228.

IMP-1700