Cardiologists criticize US regulator for keeping intracranial stent on marketBMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g357 (Published 22 January 2014) Cite this as: BMJ 2014;348:g357
- Deborah Cohen
The US Food and Drug Administration has been criticized for allowing an intracranial stent to stay on the market, despite evidence from a publicly funded trial that flagged up safety concerns and showed no benefit over medical therapy.
Writing in the BMJ about the Wingspan, Rita Redberg, a cardiologist at the University of California, San Francisco, and editor of JAMA Internal Medicine, and colleagues said, “New evidence has raised compelling questions about the safety of intracranial stenting and, more broadly, on the process by which these stents gained approval.”1
They pointed out that that for every 11 patients treated with the Wingspan, which is made by the US medical technology company Stryker, one additional patient had a stroke or died.
The device was initially approved by the FDA under a fast track scheme, the so called Humanitarian Device Exemption program. This allows high risk devices used to treat rare conditions (those affecting fewer than 4000 people in the US a year) on to the market on the basis of a smaller number of studies than in more stringent routes.
The FDA approval study …