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ABIOMED Home > News > ABIOMED Provides AbioCor® Update |
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| ABIOMED Provides AbioCor® Update | ||||||||||||||
| 9Danvers,
Mass., October 21, 2004 -- ABIOMED, Inc. (NASDAQ: ABMD) announced
today that the company has completed its clinical, engineering, and
manufacturing analyses following the death of AbioCor patient Mr.
Don Graham on September 26th. The failure of his device was caused
when two factors combined to place excessive loads on the system,
resulting in the early wear-out of a bearing. First, Mr. Graham had
a small cardiovascular anatomy resulting in a unique device orientation
within his chest. Second, his particular device had a shutter that,
although within specifications, had a limited range in controlling
left and right blood flow. The combination of these factors required
more demanding settings on the device to manage flow control than
had been previously experienced in either bench or clinical testing.
Separately, neither of these conditions would create abnormal wear,
but together they created an operating condition that led to the early
bearing wear-out.
"While we were able to give Don an additional 147 days with his family, we regret that we were not able to extend his life longer, especially since plans were being made for him to return home," commented Michael R. Minogue, CEO and President of ABIOMED. "Don was a hero, and we are grateful to him and his family for the contribution they made on behalf of all heart failure patients. We have learned from our experiences and our entire team will remember his courage as we work to further improve the AbioCor." As a result of this investigation, ABIOMED has initiated immediate actions to help prevent this situation from recurring. These actions will include changes in the manufacturing selection process of the shutter and guidelines for device and patient management. "Our application to the FDA for commercial approval under a Humanitarian Device Exemption is on track and proceeding as expected," added Mr. Minogue. "Of course, we have remained in close contact with the FDA throughout this investigation and will continue to do so." Don Graham, 73, from New Albany, Indiana, received the AbioCor on May 3, 2004 in a surgery conducted by Drs. Laman Gray and Rob Dowling, investigators for the AbioCor clinical trial at Jewish Hospital/University of Louisville. He is survived by his wife Bonnie and other family members. "After our experience with 7 patients, we believe the AbioCor has the potential to provide significant benefits to patients with heart failure who otherwise have no hope," commented Dr. Gray. "During Mr. Graham's 147 days on support he had no evidence of stroke and was able to celebrate a birthday and anniversary, take trips outside the hospital, and spend time with family and friends." One patient currently remains on support at Jewish Hospital in Louisville. Implanted on May 23, 2004, the patient remains under intensive care as a result of conditions including organ complications that pre-dated the AbioCor implant. Candidates for the AbioCor clinical trial must suffer from biventricular
heart failure, be ineligible for heart transplantation and not able
to be helped by any other available therapy, and have a high probability
of dying in less than 30 days. In September 2004, ABIOMED applied
for initial FDA market approval for the AbioCor to treat a defined
subset of irreversible end-stage heart failure patients under a
Humanitarian Device Exemption. ABOUT ABIOMED Contacts: Daniel Sutherby FORWARD-LOOKING STATEMENTS
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