Portal de Periódicos da CAPES

Presumed safe no more: lessons from the Wingspan saga on regulation of devices

2014; Volume: 348; Issue: jan22 2 Linguagem: Inglês

10.1136/bmj.g93

1756-1833

Ari J. Gartenberg, Ariel Peleg, S. S. Dhruva, Rita F. Redberg,

Intracranial Aneurysms: Treatment and Complications

Despite a randomized controlled trial showing clear safety concerns with the Wingspan intracranial stent system, the device remains on the market. Ari J Gartenberg and colleagues argue that the exemption system used to obtain its market approval in the US is not adequate for high risk devices