Stent Remains Available Despite Trial Showing Dangers

January 24th, 2014

Stent Remains Available Despite Trial Showing Dangers

Larry Husten, PHD

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. A total of 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.

Now, in a paper published in BMJ, a group of physicians led by Rita Redberg say that by not removing Wingspan from the market the FDA is shirking its “responsibility to protect the public’s health.”

The Wingspan saga shows how high risk devices can come to the market based on low quality clinical data. Furthermore, the Wingspan device has not been removed from the market, even though a high quality randomized trial was prematurely terminated because of harms and no benefit. When devices are approved under the humanitarian exemption, restriction of their use to within randomized controlled trials could prevent potentially dangerous devices from obtaining seemingly permanent market approval.”

Although the FDA issued a safety communication in response to SAMMPRIS, Redberg and colleagues write that it is “vague in its terminology” and that the Wingspan page on the Stryker website does not mention the more restricted indication. The authors cite data from Stryker showing that the company shipped 11,000 Wingspan devices in the six years following the initial HDE approval study.

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January 24th, 2014