A few weeks ago we reported on the distant clouds that appear to be building with regard to shrinkage of next generation Drug-Eluting Stents. Our original report here detailed longitudinal shrinkage which was reported by Bloomberg and discussed at this year’s Transcatheter Cardiovascular Therapeutics(TCT2011) meeting in early November.
MassDevice have updated us with news that FDA is now taking a proactive stance and working with manufacturers including Boston Scientific to better understand the issue. Their article can be found here and details how at least two studies and one case study presented at TCT2011 reported incidents in which either a Boston Scientific Ion or Promus stent deformed after it was deployed inside a coronary artery.
It seems as though there is a degree of controversy about whether the deformation of these thin-wire stents is a function of simple mechanics or a result of damage during their insertion. FDA’s conclusion at the present time is that these devices are safe if used as approved, but medlatest will monitor proceedings.
“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.