The US Food and Drug Administration (FDA) has approved labeling changes for the Stryker Wingspan Stent System, including the indications for use.
The changes were outlined by FDA in a safety communication and specify a more limited group of patients who may benefit from the system. It recommends physicians to select patients carefully after reviewing the device labeling.
According to FDA, the labeling changes for the Stryker include modified indications for use, new contraindications and warnings and a clear description of the device risks.
FDA Center for Devices and Radiological Health director Jeffrey Shuren, MD said patient benefit is a vital factor in agency decision-making.
"After careful consideration of available safety information, the FDA believes this device should remain available for this specific subgroup of patients who have exhausted other options," Shuren said.
