FDA narrows indications for Wingspan intracranial stent system

Stryker’s Wingspan stent is used to open narrowed arteries within the brain in patients who are experiencing repeated strokes. This is a serious condition with few treatment options. The device was originally approved by FDA in 2005 as a Humanitarian Use Device (HDE), a category for rare conditions.

FDA has changed the labeling of this device to limit the use of Wingspan to a narrow, select group of patients and conditions. These changes are based on the analysis of the original clinical study that led to approval, and data from subsequent studies, including the Stenting vs Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS) study.

The indications for use are now limited to a specific group of patients with severe arterial narrowing in the brain who have continued to have strokes despite medical therapy and who have not had symptoms for 7 days prior to planned treatment with Wingspan.

Wingspan is now approved only for patients who are between 22-80 years old AND who meet ALL of the following criteria:

  • who have had two or more strokes despite aggressive medical management
  • whose most recent stroke occurred more than seven days prior to planned treatment
  • who have 70-99% narrowing of an artery in the brain related to the recurrent strokes
  • who have made a good recovery from previous stroke and have a low score on a scale of disability

The FDA safety communication may be viewed here