Abiomed to slow rate of enrollment in AbioCor clinical trial to address some adverse events in some patients.
Abiomed, Inc., Danvers, MA, announced it is slowing the rate of patient enrollment in the clinical trial of its AbioCor Implantable Replacement Heart in order to address adverse neurological events sustained by some recipients of the device.
The company says the rescheduled rate of patient enrollment for the 9 remaining AbioCor implants in the trial means it does not expect to meet its previous target date of June 30. Abiomed says it still anticipates submitting a request to the US Food and Drug Administration (FDA) sometime before the end of 2003 for initial permission to sell the AbioCor for limited patient indications in the US.
Abiomed says it has completed the training of all of its US clinical sites and continues to move closer to initiating implantation of the device in selected European countries and Israel.
The company admits results have been mixed for AbioCor recipients thus far. Of the 6 patients implanted with an AbioCor, 4 have died since clinical trials began in July 2001. Abiomed adds that 4 of the 6 patients enrolled in the initial clinical trial survived for more than 60 days or double their life expectancy at the time of their surgery. To date none of the deaths have been directly attributable to the AbioCor device.
Contact: Edward Berger, PhD - (978) 777-5410
