FDA clears Abiomed devices for circulatory support
Abiomed, a provider of heart support technologies, has received 510(k) clearance from the FDA for its Impella 5.0 and Impella LD Circulatory Support Devices, designating they can provide circulatory support for up to six hours.
Similar to the Impella 2.5, which received 510(k) clearance on June 2, 2008, for partial circulatory support for periods of up to six hours, the Impella 5.0 and Impella LD devices are minimally invasive catheter-based pumps, according to the Danvers, Mass.-based company. The pump is approximately the size of a pencil with a small, nine French (3 mm diameter) catheter, which drives up to five liters of blood flow per minute.
Similar to the Impella 2.5, which received 510(k) clearance on June 2, 2008, for partial circulatory support for periods of up to six hours, the Impella 5.0 and Impella LD devices are minimally invasive catheter-based pumps, according to the Danvers, Mass.-based company. The pump is approximately the size of a pencil with a small, nine French (3 mm diameter) catheter, which drives up to five liters of blood flow per minute.