Did you suffer a stroke following a brain stenting procedure that involved use of Stryker Corp.’s Wingspan Brain Stent System? The Wingspan Brain Stent System is approved for use in patients who have had one stroke and are at risk for additional strokes. Our firm is actively investigating reports that patients treated with the Wingspan Brain Stent System face a high risk of death, and are actually more likely to suffer a subsequent stroke compared to those treated with traditional drug therapies. The defective medical device lawyers at Parker Waichman LLP want to hear from anyone who suffered a stroke following treatment with Stryker’s Wingspan Brain Stent System.If you or someone you care about were injured by the Wingspan Brain Stent System, we may be able to help you obtain compensation for medical bills, lost wages, pain and suffering and other damages in a lawsuit against Stryker Corp. Our defective medical device lawyers are offering free lawsuit evaluations to all victims of the Wingspan Brain Stent System. To learn more about the legal help available to you, please contact our Wingspan Brain Stent injury lawyers today.
Wingspan Brain Stent System May Heighten Risk of Stroke, Death
The Wingspan Brain Stent System was approved by the U.S. Food & Drug Administration (FDA) in 2005 as a humanitarian use device. It is used to place a stent (a small wire mesh tube) in narrowed arteries that supply blood to the brain in patients who have suffered a stroke or transient ischemic attack and remain at high risk of stroke. The Wingspan was designed to be used in very delicate, hard-to-reach areas of the brain, and is significantly smaller than the stents used to open arteries in the neck or heart.
Approval protocols for a humanitarian use device (HDE) are less stringent that those for other medical devices. As such, the manufacturer of the Wingspan Brain Stent System did not have to provide evidence that it was effective prior to its approval. In fact, the Wingspan Brain Stent System was approved on the basis of a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than drug therapy alone.
In 2011, a study funded by the National Institutes of Health (NIH) found that the Wingspan Brain Stent System actually increases the risk of subsequent strokes and death. The study, published in September 2011 in the New England Journal of Medicine, showed a more than 2.5-fold increase in strokes or death caused by the Wingspan system. Out of the 451 patients studies, those who underwent intracranial stenting had a 14.4 percent risk of stroke or death within 30 days, growing to 20 percent at one year. The control group using medications had a 5.8 percent and 12.2 percent risk for the same timeframe. The trial had to be halted before reaching a full enrollment of 764 patients because of the increased risk for patients receiving the stent. The study authors concluded that there is no longer “a reasonable basis from which to conclude that the probable benefit to health from the use of the device outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available alternative forms of treatment.”
In December 2011, the patient advocacy group, Public Citizen, petitioned the FDA to revoke the HDE approval for the Wingspan Brain Stent System. The group also called on Stryker to recall the device from the market.
Legal Help for Victims of Wingspan Brain Stent System Injuries
If you or a loved one suffered a stroke following a procedure with the Wingspan Brain Stent System, you may have valuable legal rights. To learn more about filing a Wingspan Brain Stent injury lawsuit, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529) today.