Stryker Wingspan Stent Recall Should Be Issued Due to Risks: Petition
The Stryker Wingspan brain stent should be removed from the market due to serious and potentially life-threatening safety issues, according to a petition filed by Public Citizen, a prominent consumer advocacy group.
Public Citizen is urging the FDA to pursue a Stryker Wingspan recall, saying that clinical trials have shown that the device, which is supposed to prevent strokes, appears to increase the risk of both strokes and deaths.
The Public Citizen brain stent recall petition comes after the cancellation of clinical trials this summer due to a high rate of strokes and deaths among test subjects implanted with the Wingspan stent.
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The Stryker Wingspan is narrow mesh tube implanted in narrowed arteries to the brain to prevent strokes in people who have already suffered one. The stent was approved as a humanitarian use device (HDE), which allowed Boston Scientific, the original designer, to get it approved with only one uncontrolled trial of 45 patients, Public Citizen stated.
In April, the U.S. National Institute of Neurological Disorders and Stroke (NINDS) ordered a halt to further clinical trials of the Wingspan after almost 15% of the patients implanted with the Wingspan suffered strokes or died in the first month. The trial included 451 patients, half of whom were treated with the Wingspan and a drug regimen of Plavix and aspirin, and the other half treated with just drugs alone. Only 6% of those given just the drugs suffered strokes or death.
An independent monitoring board stopped the trials, saying it was unethical to continue. The findings were published in September in the New England Journal of Medicine.
“The message from the trial could not be clearer. The risks of this intervention substantially outweigh any potential benefit to patients,” Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group, stated in the press release. “The device poses an imminent threat of serious harm to patients and should be pulled from the market without further delay.”
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