Boston Scientific Heart Stent News

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July 13th, 2005

"FDA will take no further action against Boston Scientific Corp.’s heart stents"

Despite reports of more injuries related to Boston Scientific Corp.’s heart stents, the FDA said they did not plan on taking any further action against the company. Last year, Boston Scientific recalled more than 99,000 Taxus heart stents following reports of malfunctions.

Boston Scientific is responsible for two-thirds of the market for drug-eluting stents, but an FDA spokeswoman said the agency does “not consider the number or type of adverse events high or inconsistent with what are the known complications with these devices.” Even after the heart stent recall issued last year, the Wall Street Journal reported doctors continued to report problems with the Boston Scientific devices.

Heart stents are tiny wire-mesh tubes that prop open heart arteries after fatty deposits have been cleared. After the heart stents are inserted through blood vessels, a tiny balloon is inflated, pushing the stent into place. Noting at least 45 reports of difficulties with balloon deflation in the devices 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.

A Boston Scientific spokesman said the heart stents continue to perform well with few complications, but shares were down nearly two percent in midday trade on the New York Stock Exchange.