A leading critic says that the FDA has been remiss for not removing a stent from the market although strong evidence exists that its use leads to more deaths and strokes.
The Wingspan intracranial stent, manufactured by Stryker Neurovascular, was approved in 2005 by the FDA through the humanitarian device exemption (HDE) for the rare condition of intracranial atherosclerosis. The approval was based on one single-arm study of 45 patients. But then in 2011 came the startling results of a much larger and well controlled trial from the NIH. 451 patients were randomized in the SAMMPRIS trial to either aggressive medical therapy or the same medical therapy plus stenting with the Wingspan stent system. The trial was terminated early due to a much higher rate of stroke or death in the Wingspan group. In response to SAMMPRIS the FDA narrowed the indication for Wingspan but did not remove it from the market.