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Just the Dates


Posted by mddiadmin on July 1, 2003


Originally Published MX July/August 2003

BUSINESS NEWS


Guidant's guilty pleas relate to failure to report more than 2600 implantation malfunctions that are believed to have resulted in 12 deaths, and more than 50 emergency surgeries, in the period from 1999 to 2001. Following is a chronology of the short, troubled market life of the Ancure endograft system.


September
1999:
  FDA
approves Ancure for U.S. market.
October
2000:
  FDA
receives anonymous letter from seven EVT employees, claiming cover-up of
delivery problems.
March
2001:
  Guidant
voluntarily withdraws Ancure system, citing problems with the delivery procedure.
September
2001:
  FDA
permits Ancure return to market, with revised labeling and physician use
instructions.
August
2002:
  Guidant
acknowledges it is subject of criminal investigation.
June
2003:
  Guidant
admits wrongdoing, agrees to $92.4 million fine.
October
2003:
  Ancure
system to be withdrawn from the market.

Copyright ©2003 MX


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