Dangerous Stent That Increases Risk of Stroke and Death Remains on Market

Dangerous Stent Remains Available on Market

The Wingspan intracranial stent, manufactured by Stryker Neurovascular and used in the case of Intracranial Atherosclerosis, was approved in 2005 but has come under fire in recent days after the release of several studies.  One of those studies, conducted by the National Institutes of Health, included 451 patients and involved a two groups of participants: one group received aggressive medical therapy and the other group received the same medical therapy in addition to the stent.  That trial was prematurely cut short because of a shocking number of strokes and deaths associated with the stent.

FDA Narrows Indication But Doesn’t Remove Stent from Market

In response to the large-scale study, also known as the SAMMPRIS, the FDA narrowed the indication for Wingspan but did not remove it from the market altogether.  This move has caused an uproar among some doctors; a recent study published in the British Journal of Medicine depicted this dissatisfaction with the FDA’s decision.  A group of physicians led by Dr. Rita Redberg says that by not removing the Wingspan from the market, the FDA is failing to fulfill its “responsibility to protect the public’s health”.

Wingspan Distribution Still High Despite Study

Unfortunately, even after the FDA’s safety communication following the SAMMPRIS study, the Stryker website does not mention the restricted indication of the Wingspan.  In addition, the BMJ article referenced above cited statistics showing that Stryker sent out 11,000 Wingspan devices in the six years following an initial (albeit smaller) study showing preliminary evidence of increased risk of strokes and deaths in patients with the stent.