Jeffrey J. Popma, MD, director of interventional cardiology clinical services at Beth Israel Deaconess Medical Center, and professor of medicine at Harvard Medical School, presents the ongoing, prospective, single-arm FDA post-approval study for the PMA approval of Impella 2.5® and Impella CP® in high-risk PCI. PROTECT III follows the PROTECT II Randomized Controlled Trial (RCT). Patients in PROTECT III are statistically older, received longer support, and had more complex procedures with more vessels treated than patients in PROTECT II. Yet the 90-day MACCE rate in PROTECT III is lower than the intra-aortic balloon pump (IABP) control arm from PROTECT II. 

PROTECT III 2-year interim report with ongoing enrollment - presented at TCT 2019