FDA Approves Blood Pump System for Heart Function Stabilization

The FDA has approved a miniature blood pump system known as Impella 2.5 System; the device is used to help stabilize circulation and heart function during high-risk percutaneous coronary intervention (HRPCI) procedures including stenting and balloon angioplasty.

The system works by pulling blood from the left ventricle of the heart and pumping it through the aorta. The Impella 2.5 System is inserted through a catheter with the pump installed into the tip. The interventional cardiologist accesses the heart by inserting the catheter into a large artery (typically in the leg) and then guides the catheter’s tip through the arteries and into the left ventricle.
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The efficacy of the device was determined through clinical data from PROJECT II clinical study (conducted by Abiomed, Inc.). Some supporting details were also obtained from the multi-center, observational registry, USpella Registry.

The study showed that the system provided circulatory support a longer and more thorough HRPCI procedure by thwarting episodes of poor circulation, low blood pressure, and other types of hemodynamic instability caused from acute heart function abnormalities.

Researchers noted that fewer future adverse events should occur in those undergoing HRCPI with the Impella 2.5 System compared to patients undergoing HRPCI with an intro-aortic balloon pump.

The complete report is published on the US Food and Drug Administration’s website.

-Michelle Canales Butcher

Reference:

US Food and Drug Administration. FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures. March 23, 2015. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm439529.htm. Accessed March 26, 2015.