Abiomed’s HDE application
This article was originally published in The Gray Sheet
Executive Summary
AbioCor humanitarian device exemption is "on track and proceeding as expected," despite the early wear-out of a bearing that resulted in the death of a patient implanted with the artificial heart, CEO Michael Minogue says Oct. 21. According to the firm's investigation, the premature bearing wear-out was due to a combination of the patient's cardiovascular anatomy and the limited range of a shutter to control blood flow, which placed excessive loads on the system. The firm has taken immediate actions to prevent recurrence, including changing the manufacturing selection process of the shutter and guidelines for device and patient management, Abiomed reports. Under the Sept. 1 HDE, the firm is seeking an AbioCor indication to treat a defined subset of irreversible end-stage heart failure patients (1"The Gray Sheet" Sept. 13, 2004, In Brief)...