DANVERS, Mass.--(BUSINESS WIRE)--Sep. 1, 2009--
Inc. (NASDAQ: ABMD),
has been informed by Mark Anderson, M.D., associate professor of surgery
at UMDNJ-Robert Wood Johnson Medical School and chief of the section of
cardiac surgery at both the medical school and Robert Wood Johnson
University Hospital, that the first patient to receive the commercial
AbioCor® Total Replacement Heart, died on August 23, 2009, due to
post-operative conditions unrelated to the device. The device was
implanted in the patient in June 15, 2009 and was operating
successfully, however the patient’s pre-existing medical conditions
precluded a full recovery with the AbioCor.
The 76-year-old male patient was diagnosed with congestive, end-stage
heart failure and did not qualify for a heart transplant or other
available therapies, making him eligible for the AbioCor implant. This
was the first patient to receive an AbioCor implant since the completion
of clinical trials and Humanitarian Device Exemption (HDE) approval from
the U.S. Food and Drug Administration (FDA) on September 5, 2006. He is
survived by his wife and other family members.
No further information is available at this time.
"Our thoughts and prayers are with the family," said Michael R. Minogue,
Chairman, President and Chief Executive Officer of Abiomed.
Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of
medical devices that provide circulatory support to acute heart failure
patients across the continuum of care in heart recovery. Our products
are designed to enable the heart to rest, heal and recover by improving
blood flow and/or performing the pumping of the heart. For additional
information please visit: www.abiomed.com.
This Release may contain forward-looking statements, including
statements regarding development of Abiomed's existing and new products,
the Company's progress toward commercial growth, and future
opportunities and expected regulatory approvals. The Company's actual
results may differ materially from those anticipated in these
forward-looking statements based upon a number of factors, including
uncertainties associated with development, testing and related
regulatory approvals, including anticipated future losses, complex
manufacturing, high quality requirements, dependence on limited sources
of supply, competition, technological change, government regulation,
future capital needs and uncertainty of additional financing, and other
risks and challenges detailed in the Company's filings with the
Securities and Exchange Commission, including the Annual Report filed on
Form 10-K. Readers are cautioned not to place undue reliance on any
forward-looking statements, which speak only as of the date of this
Release. The Company undertakes no obligation to publicly release the
results of any revisions to these forward-looking statements that may be
made to reflect events or circumstances that occur after the date of
this Release or to reflect the occurrence of unanticipated events.
Source: Abiomed, Inc.
Aimee Maillett, 978-646-1553