Ancure Aorta Patch

Modified on 2009/10/14 21:51 by admin
Aorta patches are used to correct abdominal aortic aneurysms (AAA), which are bulges in the wall of the primary artery leaving the heart. Aortic aneurysms can be fatal.

In March 2001, Guidant Corp., the maker of the Ancure aorta patch, announced a recall of unused Ancure patches. Ancure patches already placed in patients are not subject to the recall. According to Guidant, the Ancure patches involved in the recall have "deficiencies." The company has refused to elaborate.

In June 2003, EndoVascular Technologies, Inc. (EVT) a subsidiary of Guidant Corp., agreed to pay fines of $92.4 million after pleading guilty to 10 felonies for not disclosing malfunctions of their Ancure Endograft System. The fines are the largest of their kind to date.

As part of the plea agreement, the company admitted that it failed to inform the FDA of more than 2,600 system malfunctions and adverse events (a failure rate of more than 35%), including 12 deaths and 57 emergency surgeries to take out the apparatus.

See your doctor if you have experienced serious health problems after receiving an Ancure patch. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

See Also

  1. Heart Devices: Overview
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