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Blood Pump System for Patients Undergoing High-Risk PCI Receives FDA Nod
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The FDA announced approval of a miniature blood pump system to help patients undergoing certain high-risk PCI procedures maintain stable heart function and circulation.
The system (Impella 2.5, Abiomed) is intended for temporary use in patients with severe symptomatic CAD and diminished but stable heart function who are undergoing high-risk PCI and are not candidates for CABG, according to a press release.
The Impella 2.5 draws blood from the left ventricle and pumps it into the aorta, and is placed via catheter before the procedure, according to the release.
The approval was based in part on data from the PROTECT II clinical trial and the multicenter, observational USpella registry. These data indicated that the system was associated with fewer episodes of hemodynamic instability due to temporary abnormalities in heart function, and with fewer later adverse events, compared with an intra-aortic balloon pump, according to the release.