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FDA sees no more action on stents despite injuries

July 13, 2005

CHICAGO (Reuters) – U.S. regulators on Wednesday said they
do not plan to take further action against Boston Scientific
Corp.’s heart stents, despite reports of more injuries related
to the devices.

Boston Scientific, which commands nearly two-thirds of the
lucrative market for drug-eluting stents, last year recalled
more than 99,000 Taxus heart stents following reports of
malfunctions. This, plus recalls from other major medical
device companies, have weighed on the sector.

“We do not consider the number or type of adverse events
high or inconsistent with what are the known complications with
these devices,” said Julie Zawisza, a spokeswoman for the
agency, in comments sent to Reuters by e-mail.

On Wednesday, the Wall Street Journal reported that doctors
continued to report problems with Boston Scientific’s heart
devices after a voluntary recall of the devices last summer.

Boston Scientific shares dipped 51 cents to $27.35 in
midday trading on the New York Stock Exchange, while the shares
of competitor Johnson & Johnson fell 32 cents to $64.46.

Stents are tiny wire-mesh tubes used to prop open heart
arteries after fatty deposits have been cleared away. The
devices are inserted through blood vessels and deployed by a
tiny balloon that is inflated, pushing the stent in place.

The Wall Street Journal noted at least 45 reports of
difficulties with balloon deflation and 86 cases in which
balloons became stuck and were difficult to remove from
patients. The problems resulted in three deaths and several
injuries, the paper reported.

Boston Scientific spokesman Paul Donovan said the devices
continue to perform well with few complications.

“More than 1 million Taxus stent systems have been
implanted and the complaint rate has been exceedingly low,” he
said.

“Overall, we were a bit surprised to see the top billing
given to this article by the newspaper,” Morgan Stanley analyst
Glenn Reicin wrote in a research note.

“We cannot help but notice the similarities between the
Wall Street Journal’s attempt to portray Boston Scientific as a
company that is failing to address quality problems and the New
York Times’ attempt to make a similar case against Guidant .”

“The article brings up a bigger issue: How safe is safe
enough?” he added.

Susquehanna Financial Group analyst Mark Landy said most
investors in Boston Scientific understand that some margin of
failure or adverse reaction is associated with all medical
treatments, including aspirin.

“With both drugs and medical devices, you get bad outcomes
from time to time,” he said, adding the Wall Street Journal
report followed a series of recent reports by The New York
Times about problems with medical devices made by Guidant Corp.
“It now appears that medical devices are in cross-hairs of
journalists,” he said.




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