Danvers, Mass., September 5, 2006—Abiomed, Inc. (NASDAQ: ABMD) announced today it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its AbioCor® Implantable Replacement Heart (AbioCor). This landmark approval will provide patients suffering from heart failure on both sides of their heart (bi-ventricular) and who have no other alternative, a viable option for extending the quality of their life. The AbioCor is the first completely self-contained artificial heart that may allow patients more time at home, without wires or tubes piercing through their skin. This technology provides patients with complete mobility and remote diagnostics.
http://www.abiomed.com/news/2006_Sept_05_FDA.cfm
