Ancure

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What is Ancure?

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What is the Problem?

 

As the name implies, Ancure (as in "ANeurysm CURE") was presented to the FDA and the public as an appropriate treatment for abdominal aortic aneurysm. However, problems arose in patients who received an Ancure procedure. The FDA notified hospitals and health care professionals that "Problems associated with placement of the device within the blood vessels have been reported. When this problem occurred, it was found to be associated with damage to the artery wall." In the same statement, the FDA also noted that the product was somewhat unpredictable. " Some patients have had problems, and some have not," says the letter from the FDA. "But these devices are new, and there is no way to predict who will develop problems in the future."


Within 19 months of being released to the public, one out of every three Ancure devices used in patients had malfunctioned, for a total of about 2500 units that did not perform as expected. At least 12 deaths have been associated with malfunctioning Ancure units. These adverse reactions led the FDA to issue this warning to patients: "If you have one of these implanted grafts, it is very important that you have regularly scheduled follow-up appointments with your physician, who will prescribe periodic medical imaging examinations, such as x rays or CT scans. You should continue to have these checkups as long as you have the graft."
 

 

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