Abiomed announces protect iii presented at tct 2019 – clinical data demonstrates protected pci with impella is associated with improved outcomes

Abiomed announced the results of protect iii, 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). protect iii demonstrates a reduction in the primary endpoint of death, stroke, myocardial infarction and repeat procedures at 90 days with impella-supported protected pci, compared to protect ii. death, stroke, myocardial infarction and repeat procedures are known collectively as major adverse cardiac and cerebrovascular events (macce). the findings of this interim analysis on 898 patients were announced at the 31st transcatheter cardiovascular therapeutics (tct) conference by a member of the study’s steering committee, jeffrey j. popma, md, the director of interventional cardiology clinical services at beth israel deaconess medical center, and professor of medicine at harvard medical school. the protect series of fda clinical studies, which includes protect i, the protect ii rct and protect iii, is the largest-ever fda study of hemodynamically supported high-risk pci patients. the series has enrolled 1,366 patients as of july and includes the only fda randomized controlled trial ever conducted for hemodynamically supported high-risk pci.
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