The U.S. Food and Drug Administration today approved changes to the labeling for the Stryker Wingspan Stent System, including the indications for use. These changes, which the FDA outlined in a safety communication also issued today, specify a more limited group of patients who may benefit from the system. In addition, the safety communication also describes the new contraindications for the stent system, which is used to open narrowed arteries in the brain to prevent additional strokes.
This is a summary of a Press Release issued by the Food and Drug Administration (FDA). The link below will take you to the original press release containing complete information, including instructions about what to do if you are affected.