January 29th, 2015
FDA Approves Right Percutaneous Single Access Heart Pump
Larry Husten, PHD
Abiomed has announced that it received FDA approval for its Impella RP System, the first percutaneous single access heart pump that provides support to the right side of the heart. The approval, under a Humanitarian Device Exemption (HDE), is based on results of the single-arm Recover Right study, in which 30 patients were enrolled. The […]
December 8th, 2010
The Spin on the Impella Device: PROTECTing Whom?
L. David Hillis, MD and Richard A. Lange, MD, MBA
The PROTECT II study — a prospective, multicenter, randomized, controlled comparison of the Impella cardiac assist device (produced by Abiomed) and the intra-aortic balloon pump (IABP) in patients requiring hemodynamic support during nonemergent, high risk PCI — was stopped early based on a futility determination regarding the primary endpoint at the time of planned interim analysis. What’s […]
December 8th, 2010
PROTECT II Study of Impella Stopped Early for Futility
Larry Husten, PHD
The PROTECT II study has been stopped early. The trial had been comparing the Impella circulatory support device to the intra-aortic balloon in high-risk PCI patients. The trial was terminated after an interim analysis by the Data and Safety Monitoring Board, which reached a “futility determination… regarding the primary end-point,” according to a press release […]
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