How does the Impella® heart pump work?

June 24, 2019

The Impella Catheter is an intravascular microaxial blood pump that supports a patient’s circulatory system. The Impella CP® with SmartAssistTM Catheter can be inserted percutaneously through the femoral or axillary artery and into the left ventricle. When properly positioned, the Impella Catheter delivers blood from the inlet area, which sits inside the left ventricle, through the cannula, to the outlet opening in the ascending aorta.

Physicians and device operators monitor the correct positioning and functioning of the Impella Catheter on the display screen of the Automated Impella® Controller. The Impella devices provide active forward flow increasing the net cardiac output while simultaneously reducing the workload of the heart.

The left-sided Impella devices include Impella 2.5®, Impella CP®, Impella 5.0® and LD®. In these left-sided devices, blood is aspirated from the left ventricle (LV) through the inlet into the cannula portion of the pump and then expelled above the aortic valve into the ascending aorta.

The Impella RP® provides right heart support by aspirating blood through the inlet of the pump, placed in the inferior vena cava, and expelling through the pump outlet in the pulmonary artery.

What is the function of the Automated Impella® Controller (AIC)?

The Impella catheter is powered, monitored, and controlled using the automated Impella controller (AIC). The AIC is the primary user-control interface for Impella devices. The AIC also supplies purge fluid to the Impella catheter via an infusion pump.

What is the purge system?

The purge cassette delivers rinsing fluid to the Impella Catheter. The purge fluid (typically 5% dextrose solution in water with Heparin) flows from the purge cassette through the catheter to the microaxial blood pump to prevent blood from entering the motor. When the purge cassette is properly installed in the Automated Impella Controller, the Abiomed® logo is upright and facing you.

What are the components of the purge system?

The components of the purge system include the purge fluid and the purge cassette. The recommended purge fluid is 5% dextrose solution with 50 IU/mL of heparin. Through a built-in pressure sensor, the AIC automatically sets and adjusts the purge flow between 2-30 mL/hr to maintain a purge pressure of 300-1100 mm Hg.

What are the approved indications for use for Impella devices?

The Impella® Ventricular Support Systems have been approved for two separate indications for use: High-Risk PCI, and Cardiogenic Shock.

1. Impella is the only device with FDA approval for high-risk PCI (HR-PCI)

The Impella CP® with SmartAssist® Catheter, is a temporary (≤ 6 hours) ventricular support
device 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 CP® with SmartAssist® System 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.

For the complete Indications and Important Risk Information for Impella® devices, go to https://www.protectedpci.com/indications-use-safety-information/

2. Impella is the only device with FDA approval to allow for native heart recovery in AMI cardiogenic shock

The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist®, Impella 5.0® 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, 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.

For the complete Indications and Important Risk Information for Impella® devices, go to https://www.protectedpci.com/indications-use-safety-information/

3. Impella has an exclusive FDA approval for right heart failure

The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

For the complete Indications and Important Risk Information for Impella® devices, go to https://www.protectedpci.com/indications-use-safety-information/

When did Impella receive FDA approval?

Protected PCI:

The Impella 2.5 received the most stringent level of approval from the U.S. FDA, a pre-market approval (PMA) designating Impella as safe and effective,  for use in high-risk PCI on March 23, 2015 (P140003).1

The PMA approval designating Impella as safe and effective in high-risk PCI was extended to include Impella CP on December 1, 2016 (P140003/S008).1

The high-risk PCI approval is a first-of-its kind.  No other device is FDA approved for use in HRPCI

AMI Cardiogenic Shock:

The Impella devices received the most stringent level of approval from the FDA, pre-market approval (PMA) designating Impella as safe and effective for use in cardiogenic shock due to AMI or open-heart surgery on April 7, 2016 (P140003/S005).2 Impella is the only device designated by the FDA as safe and effective for heart recovery in AMI cardiogenic shock.

The exclusive PMA approval in cardiogenic shock was extended to the setting of cardiomyopathy and myocarditis on February 7, 2018 (P140003/S018).3

The exclusive PMA approval in cardiogenic shock was extended to the setting of peripartum and postpartum cardiomyopathy and myocarditis on February 13, 2018 (P140003/S049).4

Right Heart Failure:

The Impella RP received the most stringent level of approval from the FDA, pre-market approval (PMA) for use in acute heart failure on September 20, 2017 (P170011).Impella is the only device designated by the FDA as a safe and effective therapy for right heart failure.

Clinical IndicationHigh-Risk PCI
Impella DeviceImpella 2.5
Date of ApprovalMarch 23, 2015
FDA Press ReleaseP140003/S0041
Clinical IndicationHigh-Risk PCI
Impella DeviceImpella CP
Date of ApprovalDecember 1, 2016
FDA Press ReleaseP140003/S0082
Clinical IndicationHigh-Risk PCI: Expanded to with or without depressed ejection fraction
Impella DeviceImpella 2.5, Impella CP
Date of ApprovalFebruary 14, 2018
FDA Press Release
Clinical IndicationCardiogenic Shock: CG after AMI or Open Heart Surgery
Impella DeviceImpella 2.5, Impella CP, Impella 5.0, Impella LD
Date of ApprovalApril 7, 2016
FDA Press ReleaseP140003/S0053
Clinical IndicationCardiogenic Shock: Peripartum, cardiomyopathy and Myocarditis
Impella DeviceImpella 2.5, Impella CP, Impella 5.0, Impella LD
Date of ApprovalFebruary 7, 2018
FDA Press ReleaseP140003/S0184
Clinical IndicationCardiogenic Shock: Extended duration of use to 14 days
Impella DeviceImpella 5.0, Impella LD
Date of ApprovalMay 13, 2019
FDA Press ReleaseP140003/S0495
Clinical IndicationAcute Right Heart Failure
Impella DeviceImpella RP
Date of ApprovalSeptember 20, 2017
FDA Press ReleaseP170011B6

IMP-745
References:

  1. FDA-P140003/S004. Impella Ventricular Support Systems - P140003/S004. 2016; https://accessdata.fda.gov/cdrh_docs/pdf14/P140003S004B.pdf. Accessed 7 May 2019.
  2. FDA-P140003/S008. Impella Ventricular Support Systems - P140003/S008. 2016;
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140003S008. Accessed 7 May 2019.
  3. FDA-P140003/S005. Impella Ventricular Support Systems - P140003/S005. 2016; https://accessdata.fda.gov/cdrh_docs/pdf14/p140003s005b.pdf. Accessed 7 May 2019.
  4. FDA-P140003/S018. Impella Ventricular Support Systems - P140003/S018. 2016; https://accessdata.fda.gov/cdrh_docs/pdf14/P140003S018B.pdf. Accessed 7 May 2019.
  5. FDA-P140003/S049. Impella Ventricular Support Systems - P140003/S049. 2019; https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P140003S049
  6. FDA-P170011B. Impella Ventricular Support Systems - P170011B. 2017; https://accessdata.fda.gov/cdrh_docs/pdf17/P170011B.pdf. Accessed 7 May 2019.