Alejandro Freixes
Nov 18, 2011

Boston Scientific stents may be dangerous, says FDA

The FDA has recently begun investigating rare instances of stents shrinking or lengthening after implementation. Most notably, the Promus and Ion devices made by Boston Scientific are under scrutiny, although other drug-eluting manufacturers are also being inspected. Blame is not entirely placed, yet, on the stents, as there may be underlying surgical contributions to the malfunctions. Certain factors have been found to particularly predispose a patient to the danger, including calcification of coronary arteries and twisted blood vessels.  Some doctors are skeptical about placing blame on the stents, as they believe the problem may be due to mishandling of the technology rather than mechanical failure. However, they still support the issue being investigated thoroughly.


SOURCE: Reuters