FDA Approves Blood Pump System

The FDA today approved a miniature blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures.

The Impella 2.5 system was approved to maintain circulation and heart function during procedures such as balloon angioplasty and stenting, which re-open coronary arteries that are narrowed or blocked due to severe coronary artery disease (CAD).

The newly approved system is intended for temporary use among patients with severe symptomatic CAD and diminished, but stable, heart function who are undergoing high-risk percutaneous coronary interventions (HRPCI) but are not candidates for surgical coronary bypass treatment.

Impella 2.5 demonstrated that a longer and more thorough HRPCI procedure may be possible due to its ability to prevent episodes of hemodynamic instability. There was also evidence that patients undergoing HRPCI with the pump see fewer later adverse events than patients undergoing HRPCI with an intra-aortic balloon pump.

Once in place, health care providers can adjust the pump to maintain stable heart function and circulation; the system uses an external controller and monitor that turns the pump on and off.

“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure 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 a press release.