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FDA plans 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.

Shares of Boston Scientific dipped 45 cents to $27.41 in
morning trading on the New York Stock Exchange, while shares of
competitor Johnson & Johnson fell 10 cents to $64.68.

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.

Susquehanna Financial Group 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 that 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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