Limits Placed on Use of Stryker Wingspan Brain StentAug 9, 2012 | Parker Waichman LLP
The Food and Drug Administration is warning health care providers and patients that the indications for use and labeling for the Wingspan stent have changed to limit the use of Wingspan to a narrow, select group of patients and conditions.
The changes were made after an analysis of the original HDE clinical study and data was gathered from studies performed after the HDE approval was granted, and data from a clinical trial called the Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study.
The FDA recommends that physicians only use the Wingspan to treat patients if it has been approved ahead of time by the treating physician’s Institutional Review Board (IRB). According to the agency, the Wingspan should not be used for:
- the treatment of stroke with an onset of symptoms within seven days or less of treatment; or
- for the treatment of transient ischemic attacks (TIAs).
In the FDA’s press release, the agency also listed recommendations specific to neurologists and neuro interventionalists.
The full press release can be viewed here.