Wingspan Stent’s Benefits Don’t Justify Risks, Panel Concludes

Stryker’s Wingspan stent could be yanked from the market if the FDA heeds March 23 recommendations of its Neurological Devices Panel. In an informal vote, the panel agreed unanimously that current data on the device — which was approved via a humanitarian device exemption (HDE) in 2005 — do not support its safety and efficacy as a treatment for ischemic stroke in adults, and called for continued research on its use.
Devices & Diagnostics Letter