Safety and Efficacy
- Extensive data, including randomized controlled trial data and FDA-reviewed studies, support Impella® systems safety and efficacy.1,2,7
- Impella 2.5® and Impella CP® heart pumps maintain patient hemodynamics which may allow for more complete revascularization and reduction in major adverse coronary and cerebrovascular events (MACCE).8
- Impella heart pumps are associated with reduction of kidney injury during high-risk PCI.3
- PROTECT III, the most contemporary data, continues to show a reduction in MACCE with Impella2 pumps
All MACCE to 90 Days
Complete Revascularization Associated with Improved Outcomes
Benefits in high-risk acute coronary syndrome (ACS) patients at 1 year4
- 71% risk reduction in all-cause death
- 27% risk reduction in major adverse cardiovascular events (MACE)
- 41% risk reduction in myocardial infarction (MI)
Benefits in high-risk STEMI patients at 3 years5
- 26% risk reduction in cardiovascular (CV) death/MI
- 47% risk reduction in CV death/MI/revascularization
Meta-analysis of benefits in 11 high-risk STEMI studies6
- 29% risk reduction in CV death/MI
Protected PCI Improves Quality of Life
Clinical data demonstrate that Protected PCI improves quality of life by increasing ejection fraction, reducing NYHA class, reducing adverse events, and reducing acute kidney injury requiring dialysis.3,7,8
“PROTECT III clearly demonstrates how the evolution and adoption of Impella best practices can lead to an improvement in safety and MACCE.”
Ongoing and Upcoming Clinical Trials
Ongoing PMA study of Impella 2.5 and Impella CP demonstrating reduction in MACCE at 90 days with Impella-supported Protected PCI compared to PROTECT II.
PROTECT IV Randomized Controlled Trial
Ongoing trial to compare complete revascularization PCI with Impella to complete revascularization PCI without any planned hemodynamic support.
What is RESTORE EF?
Jason Wollmuth, MD, and Thom Dahle, MD, two of the principal investigators, discuss the impact on EF at 60-180 days after high-risk PCI with Impella support.
Clinical Trial Update with Chuck Simonton, MD
Chuck Simonton, MD, provides an update on clinical trials including PROTECT III, RESTORE EF, and PROTECT IV RCT.
- Dixon, S.R., et al. (2009). JACC Cardiovasc Interv, 2(2), 91-96.
- Moses, J., et al. (2020). Presented at TCT Connect 2020.
- Flaherty, M.P., et al. (2017). Circ Res, 120(4), 692-700.
- Généreux, P., et al. (2012). J Am Coll Cardiol, 59(24).
- Mehta, S.R., et al. (2019). N Engl J Med, 381(15):, 1411-1421.
- Bainey, K.R., et al., (2020) JAMA Cardiol.
- O’Neill, W.W., et al. (2012). Circulation, 126(14), 1717-1727.
- Dangas, G.D., et al. (2014). Am J Cardiol, 113(2), 222-228.