Posts for the 'Stents' Category
Boston Scientific Carotid Stent Recall
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 injury.
>>FDA LINK: Boston Scientific Stent Recall
Stent maker Boston Scientific violated FDA regulations
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 history of failing to properly report problems with their devices. The medical product manufacturer also recently agreed to pay $195 million to settle lawsuits filed due to problems with their recalled pacemakers and defibrillators, and they face thousands of potential drug eluting stent lawsuits from individuals who suffered a heart attack, death or reclogging of their artery after having the dangerous device implanted into their artery.
Drug Coated Stent Problems Continue
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 risk of death six months or more after the stent is implanted.
>>INFORMATION: Drug Coated Stent Problems
Drug eluting stent problems lead to sharp fall in sales over last year
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 devices, and sales data released last month reflect the continuing concern in the medical community about problems caused by drug eluting stents.
>>INFORMATION: Drug eluting stent problems
New heart stent could replace drug eluting stents for treatment of blocked arteries
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 for blocked arteries in the future.
>>INFORMATION: Drug Eluting Stent Problems
Unapproved heart stent use increases risk of problems
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 the FDA tested and approved profile. Further, the reports indicate that those heart stent patients who receive the devices “off-label”, have a higher rate of heart attacks and repeat stent procedures. The makers of these tiny devices face stent lawsuits nationwide from users who were injured.
>>INFORMATION: Heart stint lawsuits
Heart Stents and Plavix Long Term Use
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 on Plavix long term after the stent placement. The Saiontz & Kirk, P.A. heart stent lawyers are reviewing potential legal claims on behalf of individuals who must remain on Plavix indefintely, as well a those who suffered a heart attack or reclogging of the artery.
>>INFORMATION: Heart Stent Lawsuits
Heart stent alternatives could reduce risk of clots
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 and the manufacturers face lawsuits from those injured by the small mesh devices.
>>INFORMATION: Drug eluding stent problems
Maryland Stent Medical Malpractice
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 to the medical mistakes, it appears more likely that profits were a motivating factor. Read the rest of this entry »
Drug-eluting stents update: FDA Patient Safety News
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. Read the rest of this entry »
