UPDATE 2-US FDA narrows use of Stryker Wingspan brain stent

By Anna Yukhananov
WASHINGTON, Aug 8 (Reuters) - U.S. health regulators said on
Wednesday they would limit the use of Stryker Corp's
artery-opening stent for the brain, based on new data and safety
information.
The U.S. Food and Drug Administration changed the label for
the stent, called the Wingspan system, after outside advisers to
the agency in March recommended the device should not be used in
most people.
Stryker's stent is already not widely used. The company has
said it sells less than 2,000 devices each year.
But outside observers of the FDA were looking for the agency
to act after a study showed the Wingspan stent caused more harm
than anti-clotting drugs when used in stroke patients.

Stroke is the fourth-leading cause of death and a leading
cause of disability in the United States. Blocked brain arteries
caused by the build-up of fatty deposits called plaque account
for more than 50,000 of the 795,000 strokes occurring in the
United States each year.
Wingspan is meant to open blocked arteries in the brain
caused by plaque, when clot-dissolving drugs like aspirin and
Plavix do not work. The stent is supposed to improve blood flow
and prevent people who have already had a stroke from having
another one.
Plavix, known generically as clopidogrel, is made by
Bristol-Myers Squibb Co and Sanofi SA.
But a study published in the New England Journal of Medicine
showed stroke patients who were treated with both drugs and the
Wingspan stent had more than twice the rate of strokes and death
in the month after surgery compared to those treated with drugs
alone. Researchers had expected the use of stents to help
patients.
Some of the FDA's advisers called for the device to be
withdrawn from the market, where it has been sold since 2005.
But the FDA said the stent could still be useful for
patients who have had multiple strokes despite taking
medications, and have not had any new stroke symptoms within
seven days before getting treated with Wingspan.
Currently, there are no other options to treat these
high-risk stroke patients.
"After careful consideration of available safety
information, the FDA believes this device should remain
available for this specific subgroup of patients who have
exhausted other options," Dr. Jeffrey Shuren, head of the FDA's
devices center, said in a statement.
The FDA also said Stryker must improve its program to train
doctors to use the stent, and must also do a surveillance study
of how well the device works for patients who have already
gotten it.
The company was not immediately available to comment.
The FDA originally approved the Wingspan stent under a
Humanitarian Device Exemption, when the agency allows up to
4,000 medical devices to be sold each year without requiring
stringent evidence of effectiveness. To qualify, the device must
address a rare disease or condition, and show "probable"
benefit.
The trial supporting approval of Wingspan enrolled 45
patients who had a stroke caused by a blocked blood vessel in
the brain and whose medical treatment failed to prevent another
stroke.