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.
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.
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