Boston Scientific has issued a class 1 recall for their NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System due to a defect which could allow the tip of the stent delivery system to detach while it is being implanted. This could pose a risk of serious and potentially fatal… Read more.
Boston Scientific, manufacturer of the popular Taxus Express Drug Eluting Stent, has been reprimanded by the FDA for violating federal regulations when they failed to report two deaths in a clinical trial for a different type of stent. This is not the first warning for the company, which has a… Read more.
More troubling data regarding problems with drug coated stents was presented yesterday in Vienna at a meeting of the European Society of Cardiology. An international study found that those who receive a drug coated stent following an acute heart attack, instead of a bare metal stent, face a significantly increased… Read more.
Sales of drug eluting stents have fallen over the past year, following reports in October 2006 that the small devices could increase the risk of blood clots which develop months or even years after it is implanted. Doctors throughout the United States have not been as quick to implant the… Read more.
Since last fall, there have been concerns about problems with drug eluting heart stents, which could increase the risk of potentially fatal blood clots. Researchers are developing a new type of absorbable heart stent, which could provide a safer alternative to replace drug eluting stents as the primary treatment option… Read more.
Two studies published this week in the Journal of the American Medical Association (JAMA) raise additional concerns about the safety of heart stents. Although drug eluting stents (DES) are only approved to treat certain type of blockages, researchers found that over half of all stents implanted are off-label, or outside… Read more.
Drug coated heart stents have been linked to an increased risk of serious and potentially fatal blood clots which could develop years after the stent is implanted. However, there are many individuals who have not experienced a blood clot, heart attack or reclogging of the artery, yet now must remain… Read more.
Over the past six months, the use of drug eluting stents has dropped significantly. As doctors and patients have developed valid concerns about stent side effects which could cause heart attacks or potentially fatal blood clots years after the stent is implanted, alternatives to drug coated stents are being considered… Read more.
Today, Peninsula Regional Medical Center in Salisbury, Maryland announced that at least 25 unnecessary stent placements were performed by one cardiologist, exposing patients to stent problems which could lead to an increased risk of potentially deadly blood clots. While the hospital and doctor attempt to suggest a vision problem led… Read more.
In the March 2007 “FDA Patient Safety News Show”, concerns about drug eluting stents were discussed. The FDA show is designed for health professions to provide safety information and news alerts. The portion of the show discussing concerns about drug coated stents was posted on the FDA website today.
