Abiomed Gets FDA 510(k) for Impella 5.0, Impella LD VADs


April 22, 2009

April 22, 2009 - Abiomed Inc. said this afternoon it received FDA 510(k) clearance for the Impella 5.0 and Impella LD ventricular assist devices for circulatory support of periods 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 pump is approximately the size of a pencil with a small 9 Fr. 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 said.

“Formerly, only patients with a grave prognosis received aggressive circulatory support due to the invasiveness and potential complications associated with conventional surgery devices,” said Anson Cheung, M.D., surgical director of heart transplantation at St. Paul’s Hospital in Vancouver, British Columbia. “The availability of the Impella 5.0 and Impella LD has reduced our threshold to implanting patients with a temporary circulatory support device and offers a potential benefit to reduce the likelihood of escalating therapy, such as implantable devices or heart transplantation. We have already seen patient success from Impella 5.0 and LD in providing the therapeutic benefit of ventricular unloading, which helps to interrupt the progression of heart muscle damage and potentially repair reversible damage.”

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

For more information: www.abiomed.com