Stryker Corp.’s Wingspan stent may not be worth the risks because the device has no added benefit over drugs used to prevent stroke in patients with narrowed arteries in the brain, U.S. regulators said today.
The brain stent may be inferior in some cases than standard therapy for stroke prevention, including blood thinners, Food and Drug Administration staff wrote in a report today. The agency is scheduled on March 23 to convene an advisory panel to review the safety and effectiveness of the stent from Kalamazoo, Michigan-based Stryker. The FDA asked the panel to discuss whether the benefits of the stent might outweigh the risks.
The consumer group Public Citizen, based in Washington, urged the FDA to pull the stent from the market last year after the first definitive trial of the device’s safety risks was halted. Patients whose arteries were propped open with Stryker’s stent were more likely to have a stroke than patients who were treated with drugs, according to a National Institutes of Health-funded study published in September in the New England Journal of Medicine. The FDA further examined groups of patients within the NIH study.
“It is notable that all of the subgroup results point in the same direction of no added benefit, and in some cases, significantly worse outcomes,” FDA staff wrote.
Stryker rose less than 1 percent to $54.85 at the close of New York trading.
The agency asked the panel to discuss whether more clinical data should be gathered on the safety and effectiveness of the device or whether the stent might benefit patients who don’t respond to blood thinners or who have a history of stroke.
Stryker generated $750 million in neurotechnology and neurovascular product sales in 2011, according to data compiled by Bloomberg. Stryker acquired Wingspan in its 2010 purchase of Boston Scientific Corp.’s neurovascular unit. The device likely isn’t a big product for Stryker, which doesn’t break out sales, Michael Matson, an analyst with Mizuho Securities USA Inc. said in a telephone interview.
“ It’s not all that material to Stryker in the grand scheme of things,” he said.
Researchers stopped enrollment in the NIH study at 451 patients when they determined the 30-day rate of stroke or death was 14.7 percent in patients who received the stent compared with 5.8 percent in those who took drugs to treat their narrow arteries, according to the journal article.
The FDA approved Wingspan in 2005 under a humanitarian device exemption that requires Stryker prove the product doesn’t cause significant risk of illness or injury and treats fewer than 4,000 people in the U.S. a year.