FDA To Limit Use of Stryker Artery Opening Brain Stent & States It Could Cause More Harm Than Treating Patients With Drugs
Posted Aug 08 2012 11:32pm
A much smaller group of patients will now have the stent available and there have been campaigns on the web to even have the device recalled. The patients who can now have the implant are those who have had several strokes that are already on a medication treatment plan, in other words more as a last defense treatment. BD
WASHINGTON (Reuters) - U.S. health regulators said on Wednesday they would limit the use of Stryker Corp's artery-opening stent for the brain to a narrower group of patients, based on new data and safety information.
The U.S. Food and Drug Administration changed the label for the stent, called the Wingspan system, after most outside advisers to the agency in March recommended the device should not be used in the majority of patients. A study last year showed it caused more harm than anti-clotting drugs.
Wingspan is used to open blocked arteries in the brain when clot-dissolving drugs like aspirin and Plavix do not work.
The stent is supposed to improve blood flow and prevent people who have already had a stroke from having another one.
Plavix, known generically as clopidogrel, is made by Bristol-Myers Squibb Co and Sanofi SA.
But a study published in the New England Journal of Medicine showed the stent may actually do more harm than treating people with drugs and lifestyle changes.