FDA Issues Warning on Boston Scientific Heart Stents

November 20, 2011, 09:15:00AM. By Jane Mundy

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Washington, DC: A newer class of heart stents are under investigation by the FDA. According to US health regulators, these tiny tubular devices made of wire mesh may shrink or lengthen after implantation, which can potentially cause a serious problem.

As reported by the agency, drug-eluting stents that are causing the most frequent problems are those in the Promus Element (not sold in the US) and Ion devices made by Boston Scientific Corp.

Drug-eluting stents are designed to prop open damaged arteries and deliver medicine to keep them from clogging again. But if the stent becomes deformed inside the vessel, the device could create a clotting risk that could lead to a heart attack.

According to publications in the Journal of Interventional Cardiology there have been concerns that some stents are poorly designed to resist shortenting. The Journal reported one case where a patient’s artery shortened and accordioned after Boston Scientific’s Ion stent was implanted. He then suffered a heart attack.

Boston Scientific, the biggest manufacturer of stents, has more than a third of the $4 billion global market. The company has recalled a number of stents that date back to 2004.

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