FDA Investigating Problems Where Drug Eluting Stent Shrink or Lengthen

Federal regulators are investigating reports involving problems with drug-eluting stents, where the small wire devices may become deformed once implanted in patient arteries. 

The FDA is investigating issues with drug-eluting stents, specifically involving Boston Scientific’s Ion and Promus stents, following a study that suggests some of the stents are shrinking or changing shape inside patients’ bodies. The study was published online in the Journal of Interventional Cardiology, and was discussed at the Transcatheter Cardiovascular Therapeutics meeting in San Francisco earlier this month.

According to the research, lead by Dr. Cindy Grines, a Wayne State University researcher and editor of the journal, a stent involved in one case shrunk by about 35%. Grines believes that the deformation of the stent caused stent thrombosis and is of serious concern.

The FDA has acknowledged it is investigating the matter, primarily due to a number of reports involving the Boston Scientific Ion stent. However, at this time, the agency says it believes the stents are safe and effective. Investigation of the Promus is also included, but to a lesser extent, since there has only been one report of stent shrinkage related to that brand.

Abbott Laboratories, which uses Grines as a consultant, conducted a study showing that the Ion could potentially shrink up to 46 percent and suggested that the shrinkage could be related to how the stents are implanted.

Coronary stents are wire mesh tubes inserted into previously clogged arteries to prevent them from closing again and possibly causing the recipient to suffer a heart attack or other coronary problems. The drug-coated stents, also known as drug eluting stents, are covered in medication meant to prevent the formation of scar tissue that may clog the stent.

In recent years, some experts have questioned the widespread popularity of stent placements, indicating that many patients may be able to treat their conditions with medication or diet.