Abiomed has developed a new Portable Circulatory Support Driver for both in-hospital and out-of-hospital patients, designed to support its AB5000 ventricular assist device (VAD).
The Danvers, Mass.-based Abiomed said the combination of its new Portable Driver and FDA-approved AB5000 VAD provides support of acute heart failure patients. The AB5000 can assume the pumping function of a patient’s failing heart, allowing the heart to rest, heal and potentially recover, according to the company.
Abiomed also said that it has received FDA labeling approval of one year bench reliability for its AB5000 VAD.
The Portable Driver is a bi-ventricular system which delivers the pressures and vacuums equivalent to Abiomed’s AB5000 console and its recently approved iPulseTM console, and weighs only 18 pounds, according to the company.
The FDA has not yet approved Abiomed’s Portable Driver, but the AB5000 VAD has CE mark approval in Europe. Abiomed said it expects to start supporting patients with the Portable Driver in Europe in its fiscal fourth quarter ending March 31.