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FDA Advisors See Risks from Wingspan Brain Stent

Mar 26, 2012 | Parker Waichman LLP

Federal health regulators have been advised to rethink the approval of Stryker Corp.'s Wingspan Brain Stent, a stent used to prevent strokes in patients who have suffered one previously.  A majority of outside experts on a 16-member U.S. Food & Drug Administration (FDA) advisory panel agreed Friday that available data indicates the risks of the Wingspan Brain Stent outweigh its benefits.

The Wingspan stent is used to open blocked arteries in the brain when clot-dissolving drugs like aspirin and Plavix do not work.  The device is the only stent on the market which is approved for use in certain high-risk stroke patients  It was approved by the FDA in 2005 under its   Humanitarian Device Exemption program, which allows for clearance without proof that a device is safe or effective.  Only a single, non-controlled 45-patient study was review by the FDA before it cleared the Wingspan for sale.

Recently, however, concerns have been mounting that the Wingspan Stent may be doing more harm than good. In September, a study published in the New England Journal of Medicine found patients who had received the device were found to have a 2.5-fold increase in stroke or death compared to those treated with blood-thinning medications. 

That study prompted the group Public Citizen to call for a recall of the device.  At Friday's meeting, a representative from the group renewed that call.

"The credibility of the FDA is on the line," said Dr. Michael Carome, deputy director of Public Citizen's Health Research Group. "Patients will continue to be harmed unless the FDA withdraws its approval."

In the end, most of those on panel agreed the benefits of the Wingspan Stent did not outweigh its risks.  They recommended that the FDA reconsider its approval of the device.  However, most also agreed that Stryker should keep testing the Wingspan Stent to see which patients would most benefit.
"I'm still concerned ... about that one subgroup of patients where we're backed against the wall and we have no options," said Dr. Larry Goldstein, director of Duke University's Stroke Center.

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