A dangerous device gets “humanitarian exemption.”
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Stryker Wingspan Brain Stent Stroke Lawsuit

Research shows that the Stryker Wingspan Brain Stent might cause patients to suffer strokes and experience fatal side effects.

What Is the Stryker Wingspan Brain Stent?

According to the U.S. Food and Drug Administration’s (FDA) Web site, the medical device manufacturer, Boston Scientific, developed the Wingspan Stent System and obtained approval for it in August 2005. Its purpose is to open blocked arteries in the brains of those who have suffered strokes when clot-dissolving drugs do not work. The surgeon inserts a “balloon catheter” into the blocked artery to open it up. Then he or she replaces the balloon catheter with the permanent metal stent. The metal stent is a tube-shaped, “self-expanding, metal (nitinol) mesh.” The surgeon removes the balloon and the “delivery system,” leaving the metal mesh stent in place.

Boston Scientific obtained a “Humanitarian Device Exemption” from the FDA for the Wingspan Brain Stent, meaning the FDA allowed Boston Scientific to obtain market approval for the device without demonstrating its effectiveness, simply because the manufacturer designed it to treat a rare disease or condition. The FDA considers a disease or condition “rare” if it afflicts fewer than 4,000 people in the United States in any given year. Later, Boston Scientific permitted Stryker Corp., Inc. to begin manufacturing the Wingspan Brain Stent.

The Stryker Wingspan Brain Stent Might Cause Strokes and Death

In September 2011, the New England Journal of Medicine published a study (called “SAMMPRIS”) of 451 patients conducted by the U.S. National Institute of Neurological Disorders and Stroke (NINDS). NINDS compared the effectiveness of the conventional medical response to those who suffered strokes with the same medical response and implantation of the Wingspan Brain Stent. The researchers stopped the study because they determined that 14.7 percent of the patients with the stent suffered a subsequent stroke or died. They concluded that the conventional medical response was superior to the Wingspan Brain Stent. The device actually increases the risk of stroke or death in recipients by 2.5 times, and one recipient of the Wingspan Brain Stent out of every 11 suffers a subsequent stroke within 30 days or dies compared to those who do not receive the device.

Based on these findings, on December 21, 2011, the advocacy group Public Citizen sent a petition to the FDA requesting that it both withdraw its approval of the Wingspan Brain Stent system and order a Stryker Wingspan Brain Stent recall of all unused stents. According to the organization, the FDA gave Boston Scientific the humanitarian device exemption based on “a single, uncontrolled trial of just 45 patients that was not designed to demonstrate whether the device was more effective or even safer than medical therapy alone.”

The FDA justified its decision not to order a Stryker Wingspan Brain Stent recall by claiming that the SAMMPRIS study’s participants’ conditions differed from those in the uncontrolled, 45-patient trial on which if based its decision to give the brain stent a humanitarian device exemption. On January 12, 2012, Public Citizen filed an addendum to its December 2011 petition, pointing out that the trials’ separate groups was not a reason to discount the SAMMPRIS study’s findings and that the studies’ participants’ conditions were largely similar.

In March 2012, the FDA published an executive summary (PDF) of the Wingspan Brain Stent’s effectiveness in anticipation of a meeting of the Neurological Devices Panel, which would determine the device’s fate. The document found that “it is notable that all of the subgroup results point in the same direction of no added benefit, nad in some cases, significantly worse outcomes associated with the [brain stent] treatment in the SAMMPRIS trial.”

Surprisingly, in August 2012, the FDA issued a new drug safety communication informing the public that it chose to restrict the Stryker Wingspan Brain Stent’s indication rather than issue an outright recall. Now, the Wingspan brain stent can only be used in adults who have had two or more strokes that require aggressive treatment. In particular, the new rules require the last stroke to be more than seven days before stent therapy can occur.

RLG’s Stryker Wingspan Brain Stent Lawyers Will Make Things Easier

The process of demanding compensation for the harm you’ve suffered can be complicated, even if it doesn’t seem fair that you should have to go through even more trouble to be made whole again. The Stryker Wingspan Brain Stent lawyers at the Rottenstein Law Group believe that obtaining legal satisfaction from those who harmed you shouldn’t require more hardship. That’s why we do everything we can to streamline the process, and we will file a Stryker Wingspan Brain Stent lawsuit on your behalf if necessary. RLG will also keep you up to date on any Stryker Wingspan Brain Stent class action lawsuits, FDA Stryker Wingspan Brain Stent warnings, and Stryker Wingspan Brain Stent FDA recall announcements. If you received Stryker Wingspan Brain Stent and believe it harmed you, contact RLG today.

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