International Biophysics, a firm out of Austin, Texas, won FDA clearance for its FloPump 32 centrifugal disposable heart pump. The device is designed to be powered by the Maquet ROTAFLOW console, which can be used as a stand alone unit or a part of a heart-lung machine. The new pump won the CE Mark approval in Europe last year.
This is one of the smaller pumps available on the market, with only a 32ml priming volume. It can move up to seven liters of blood per minute at a maximum pressure of 750 mmHg.
In the United States, the device will be distributed by Origen Biomedical, also an Austin, TX firm.