Boston Scientific Stents Could Pose Rare but Serious Probelm
Boston Scientific stents are under investigation by health regulators for a rare but serious problem where the tiny devices could pose risks by shrinking or lengthening while in use.
According to a report from Reuters, two cardiology journals published a report about stents produced by Boston Scientific. In one instance out of 4,600 patients tested with a Promus stent, it stent became deformed inside the artery it was supposed to be propping open. The deformation could lead to increased clogging, exactly what the device is supposed to prevent.
The risk of deformation inside the artery could be problems with implantation, such as improper positioning within the artery, or implanting the stent in an already twisted vessel.
Increased clotting can increase the risk of heart attack, stroke, blood clots and other cardiac problems. Boston Scientific didn't comment on the investigation.
The FDA is reportedly investigating the issue with Boston Scientific and other stent makers, though Boston Scientific controls a large part of the market. It is the largest manufacturer of stents, controlling about one third of the $4 billion worldwide market and about half of the U.S. market.
Though wildly successful with stents, the business struggled starting in 2004 with some recalls and increased debt from an acquisition of pacemaker manufacturer Guidant Corp that wasn't as profitable as previously hoped.