Abiomed wins FDA clearance for new circulatory support devices

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.

This 510(k) clearance designates Impella 5.0 and Impella LD to provide circulatory support for periods of up to six hours.

Similar to the Impella 2.5, which received 510(k) clearance in June 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, designed to provide temporary circulatory support and reduce the workload of the heart muscle, the company said.

The pump is approximately the size of a pencil with a small nine French catheter, which drives up to five liters of blood flow per minute, a flow rate typically adequate to fully support the average adult, the company added.

In application, Impella is intended to increase the flow delivered by the heart, which can potentially reduce the work of the heart and augment coronary flow.

Michael Minogue, chairman, president and CEO of Abiomed, said: Now, both cardiologists and surgeons can use the minimally invasive Impella 5.0 and Impella LD devices for critical patients whose conditions require high-flow circulatory support. This FDA clearance represents Abiomed’s ability to create new heart support technologies and execute on the regulatory path. This is the eighth FDA regulatory clearance or approval in the past four years.