| News From Transplant Week of April 7, 2002 / Vol. 3 No. 14 |
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New Trials of AbioCor Heart Delayed, But Timeline for Approval Unchanged |
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Abiomed Inc. said it would delay further clinical trials of its self-contained artificial heart, but said it is sticking to its target of seeking FDA approval to sell the revolutionary device before the end of next year. While the company has performed six trials of the AbioCor heart to date, and had planned to complete the first 15 implants by June 30th, Abiomed said it planned to delay the final nine operations to use the experience gained to "do even better with the additional patients that will be enrolled to complete the trial." The AbioCor heart became the focus of attention around the world when it was implanted last summer in the chest of Robert Tools, a 59-year-old suffering from end-stage congestive heart failure. Tools, who doctors said was not expected to survive 30 days, lived nearly five months. Of the five other recipients, one died on the operating table, two died after several months with the artificial heart, and two survive. The current longest-surviving recipient, Tom Christerson, 71, who received the AbioCor at Jewish Hospital in Louisville on Sept. 13, may be allowed to return home in another week, according to his doctors. The only other survivor of the original six men to receive the AbioCor hearts, James Quinn, 51, of Philadelphia, received his artificial heart at Hahnemann University Hospital in Philadelphia. All of the
initial patients to receive the AbioCor were dying of heart failure
and were too sick to qualify for human heart transplants. Other sources: Abiomed, Boston Globe |
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