Abiomed gets US nod to continue AbioCor trial:
This article was originally published in Clinica
Abiomed is pressing on with a clinical trial of its implantable replacement heart, AbioCor, after gaining permission from the US FDA to implant the device in another five patients. The trial will consist of a total of 15 patients, who will be assessed in groups of five. The FDA's decision comes shortly after the first patient enrolled in the trial suffered a stroke (see Clinica No 984, p 20). While noting that it has much to prove and learn, the Danvers, Massachusetts firm says that clinical results from the first five patients implanted with the device look "extremely promising".