Analysis

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

BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g93 (Published 22 January 2014) Cite this as: BMJ 2014;348:g93
  1. Ari J Gartenberg, medical student1,
  2. Ariel Peleg, medical student1,
  3. Sanket S Dhruva, cardiology fellow2,
  4. Rita F Redberg, professor of medicine3
  1. 1Albert Einstein College of Medicine, Bronx, NY 10461, USA
  2. 2Division of Cardiovascular Medicine, UC Davis Medical Center, Sacramento, CA 95817, USA
  3. 3Division of Cardiology, School of Medicine, University of California, San Francisco Suite M-1180, 505 Parnassus Avenue, San Francisco, CA 94143, USA
  1. Correspondence to: R F Redberg redberg{at}medicine.ucsf.edu

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

Use of stents throughout the vasculature has been increasing since the first coronary artery stent was introduced in 1986 to treat restenosis after balloon angioplasty. Coronary artery stenting has been shown to significantly benefit patients with acute myocardial infarction, and intracranial stents were developed in the hope that they would prevent strokes in patients with substantial stenoses who had already had strokes. In the brain, however, the procedure is far more challenging because it involves navigating a specialised, flexible device through much smaller and more tortuous vessels than in the heart. Intracranial stenting has serious possible complications, such as the formation of thrombi, which can embolize and cause acute ischemic strokes.

Two intracranial stenting devices have been marketed in the US. The first was the Neurolink system (Guidant Corporation, Menlo Park, California), which was approved in 2002 but then discontinued in 2006 in favor of the more technologically advanced Wingspan stent system (Stryker Neurovascular, Kalamazoo, Michigan).1 Treatment was once thought to be both feasible and safe, but new evidence has raised compelling questions about the safety of intracranial stenting and, more broadly, on the process by which these stents gained approval.

How the Wingspan got to market

Although cerebrovascular disease is common, intracranial atherosclerosis is considered rare. Intracranial stents are therefore able to obtain market approval in the US through the humanitarian device exemption, which is intended to offer incentives to develop devices for disease populations of fewer than 4000 individuals a year when a manufacturer’s research and development costs otherwise could exceed market returns.2 To be …

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