Abiomed medical device wins European approval
Danvers medical-device company Abiomed Inc. said today that it has gotten the approval of European Union regulators to market a power-pack (right) for one of its heart pumps in EU countries and countries that recognize EU approval.
A heart pump such as Abiomed's AB5000 ventricular-assist device, or VAD, helps patients with weak hearts, but patients must remain in the hospital close to a power source.
By connecting a VAD to the company's new Portable Driver, an 18-pound device featuring new battery technology, a patient using a VAD can be discharged from the hospital, Abiomed said
Abiomed has submitted the Portable Driver to the Food and Drug Administration so the device can be marketed in the United States, but the FDA has asked the company for additional information, Abiomed said.
(By Chris Reidy, Globe staff)
