FDA Sees Rare Serious Issue With Stents
A rare but potentially serious problem with a newer class of heart stents that results in the tiny tubular devices made of wire mesh to shrink, or lengthen, after implantation is being investigated by health regulators.
The U.S. Food and Drug Administration said the problem appears to occur most frequently in the Promus and Ion devices made by Boston Scientific Corp.
Boston Scientific, the biggest manufacturer of stents with more than a third of the $4 billion global market, declined to comment on discussions with the FDA. Boston Scientific had a 36 percent share of the global market and a 49 percent share of the U.S. market at the end of the third quarter.
The company’s business has struggled on several fronts in recent years, including a series of stent recalls that date to 2004 and a heavy debt load from its ill-fated acquisition of stent and pacemaker manufacturer Guidant Corp in 2006.
Concerns about stent deformation were raised in two smaller cardiology journals published in the United States and Europe, and the issue was the subject of a discussion at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco earlier this month.
“FDA is actively working with (drug-eluting stent) manufacturers, including Boston Scientific, to better understand longitudinal stent deformation with respect to its causes, predisposing underlying anatomic conditions, operator techniques that can reduce the likelihood of its occurrence, and treatment strategies should it occur,” the agency said.
Tags: Boston Scientific, heart stents, pacemaker, treatment strategies






