=WSJ: Guidant Charged -3: Co. Notified FDA In March 2001
Guidant itself notified the FDA in March 2001 of cases in which its
sales personnel hadn't notified the agency. The company also pulled
the device, known as the Ancure, from the market. Subsequently in
August that year, the Ancure was returned to the market. At the time,
the matter was believed to involve a small number of problems, but the
criminal information said there are more than 2,600 such cases not
reported to the FDA.
(This report and related background material will be available on
The Wall Street Journal's Web site, WSJ.com.)
Ancure is one of a small handful of federally approved devices on
the U.S. market for the treatment of aortic aneurysms, which are
bulges in the aorta that potentially can rupture and cause nearly
instantaneous death. One other such device is the Aneuryx, made by
Guidant's archrival Medtronic Inc. (MDT) of Minneapolis. It isn't
involved in this case.
The devices are known as stent-grafts because they include both a
"stent" - a coiled section of wire or other material to prop open an
artery - and a "graft," a section of fabric designed to replace the
normal aorta of a patient. The device is installed by an
interventional radiologist, vascular surgeon or other physician. The
doctor creates a surgical opening in the thigh, slides the device into
the femoral artery, up through the iliac artery and into the aorta. In
the case of the Ancure device, it is designed to be attached to the
aorta wall with miniature hooks.
The main idea of the device is to create a new, interior channel for
blood to flow through - and take pressure off the wall of the aorta so
as to minimize the risk of bursting. In most instances, the Guidant
difficulties were not so much with the device itself but rather with
the catheter apparatus used to deploy it.
The Guidant case is among the most serious recorded involving the
medical-device industry. But stent-grafts, while potentially an
advance over surgery as a means of treating aortic aneurysms, have
been plagued with difficulties during just four years on the U.S.
market.
- Thomas M. Burton, The Wall Street Journal, 312-750-4123
and Patricia Callahan, The Wall Street Journal, 312-750-4119
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+WSJ: Guidant Charged With 10 Felony Counts
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*WSJ: Guidant Accused Of Making False Statements To FDA
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*WSJ: Guidant Charges Connected To Stent-Graft Device>GDT
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=WSJ: Guidant Charged -2: Problems With Ancure Device >GDT
By Thomas M Burton and Patricia Callahan
Of THE WALL STREET JOURNAL
CHICAGO (Dow Jones)--Guidant Corp. (GDT), the big Indianapolis-based
medical device maker, was charged in a criminal information Thursday
with 10 felony counts, including false statements to the Food and Drug
Administration in connection with its "stent-graft" device it makes
for aortic aneurysms.
The company was also charged with "fraudulent" sales of "misbranded"
devices, again referring to the aneurysm stent-graft, known as the
Ancure.
The criminal information, filed in U.S. District Court in San
Francisco, relates principally to problems experienced by doctors in
installing the Ancure device - but which Guidant failed to report to
the FDA as required by federal law. The filing by federal prosecutors
said there were 12 deaths believed to relate to these cases that
weren't reported to federal authorities. Also, it charged, there are
57 unreported cases in which surgeons had to do emergency surgical
repair on the aneurysms instead of proceeding with installation of the
device. The surgical repair involves slicing open the abdomen, moving
intestines out of the way, clamping off the aorta and slicing it open,
then inserting an artificial hose to replace the artery.
A criminal information - as opposed to an indictment by a federal
grand jury - is the document federal prosecutors use when a defendant
intends to plead guilty to the charges. Guidant Corp. didn t return
numerous calls for comment.
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