This article is more than 5 years old. Information may no longer be current.
FDA approves blood pump system for patients undergoing high-risk PCI
Click Here to Manage Email Alerts
The FDA announced that it has approved 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 Inc.) 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 from the agency.
The system draws blood from the left ventricle and pumps it into the aorta, and is placed via catheter before the procedure, according to the release.
William Maisel
“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable [BP] and poor circulation, in patients who are at high risk for its occurrence,” William Maisel, MD, MPH, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in the release.
The approval was based in part on data from the PROTECT II clinical trial and the multicenter, observational USpella registry, according to the release. 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.