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The
Guidant Ancure Endograft system was designed to be
used to treat patients suffering from an abdominal
aortic aneurysm, or AAA. Ancure was approved for use
by the FDA in 1999. The product was sold as a
non-surgical alternative that would help treat
weakened blood vessels in the abdomen. The FDA based
their approval of the devices on clinical studies of
safety and effectiveness conducted by Guidant, the
manufacturer of the Ancure product. Guidant has
since stopped selling the product due to safety
concerns following several deaths and other
complications.
There
was a need for a product like Ancure. AAA is a
serious medical condition, caused when a bulge or
tear occurs in the part of the aorta that extends
into the abdomen. Although we commonly think of the
aorta as being near the heart, it actually extends
from the heart into the lower abdomen, providing
blood to the organs in the abdomen and below. In
cases of AAA, the aorta can rupture, leading to
significant blood loss and death in more then 85%
patients.
Guidant promised that Ancure was a safe and
effective treatment for patients who had AAA. Ancure
and other endografts are designed to bypass the
aneurysm by providing an alternative pathway for
blood to flow through the aorta. This reduces
pressure on the aneurysm with the intent of
preventing it from bursting. The surgically
implanted device was considered less invasive than
similar products that were available at the time.
According to Guidant, Ancure required shorter
hospital stays and recovery time for the patient.
Unfortunately, the device did not work as promised.
Within 19 months of being released to the public,
over 2500 Ancure devices had malfunctioned out of a
total 7500 sold. The product was recalled in March,
2001. Five months later, Guidant re-released Ancure
after making over 20 modifications to the design.
When problems continued, the company announced on
June 16, 2003 that the product would no longer be
sold.
While
announcing the discontinuation of the Ancure
product, Guidant tried to reassure the 18,000
patients who already have the device by claiming
that the problems have to do with Ancure's insertion
and not with the actual product itself. However, the
Food and Drug Administration (FDA) is not as
confident. In a statement sent to doctors and Ancure
patients, the FDA warned, "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."
Given Guidant's history of misinformation regarding
Ancure, there is reason for skepticism.
Guidant claimed responsibility for 12 deaths
connected to malfunctioning Ancure units, although
those who are familiar with Ancure claim that the
actual number of deaths related to the defective
product is at least 28. In April 2001, the FDA sent
a letter to health care professionals who had used
Ancure, warning them that "serious problems that
have occurred" with the device. On June 12, 2003, a
company official admitted in Federal Court that
Guidant hid key facts about its product from the
public. The company also pleaded guilty to nine
counts of introducing a misbranded medical device
with the intent to defraud or mislead.
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