FDA investigates stent "shrinkage" in Boston Scientific's Ion, Promus stents, others

November 21, 2011 by MassDevice staff

The FDA is investigating "longitudinal stent deformation" in Boston Scientific's Ion and Promus stents, but maintains that the devices are safe if used as approved.

Ion stent

The FDA is investigating reports that the thinner design of next-generation drug-eluting stents, including Boston Scientific's (NYSE:BSX) Ion and Promus models, might be prone to deforming after implantation.

At least two studies and one case study presented at a recent cardiology conference reported incidents in which either a Boston Scientific Ion or Promus stent deformed after it was deployed inside a coronary artery.

"FDA is actively working with 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 told Reuters in a email.

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Although there's been only one reported incident of deformation involving a Promus stent from among more than 4,600 implantations in clinical trials, according to the federal watchdog agency, "an unspecified number of significant adverse events had been reported to the agency," according to the news service.

"At this time, additional data collection and analyses are ongoing, but the information available to date indicates that the Ion paclitaxel-eluting platinum chromium stent remains safe and effective when used for its approved indications," the FDA said, according to Reuters.