Following studies which revealed that using stents manufactured by Stryker Corp to open clogged brain arteries could instead increase the risk of stroke and death, the US Food and Drug Administration announced that it will be limiting the use of such stents for only a small section of the patients.
FDA's announcement comes after a public safety advocacy group, Public Citizen, urged the health agency to pull the product from the market. According to the organization, using the stent increases the risk of stroke and death by 2.5 times compared to using blood thinning medicine.
AdvertisementStryker's Wingspan stent was approved by the FDA in 2005 but the health agency said that the stent will now be used only in patients who have suffered from multiple strokes but have not experienced a stroke symptom in the last seven days.
"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options", the director of the FDA's center for devices, Dr Jeffrey Shuren said.