FDA Gives New Recommendations For Stent Use After Unexpected Deaths

Agency clarifies risks associated with certain procedures

The U.S. Food and Drug Administration (FDA) has issued a series of recommendations for use of neurovascular stents for stent-assisted coiling (SAC) of unruptured aneurysms after the agency received reports of periprocedural stroke and death associated with these devices.

These events may have been related to procedural risks, patient selection, or those who were not tolerant of anticoagulation or antiplatelet therapy.

“To promote safe and effective use of neurovascular stents used for stent-assisted coiling of brain aneurysms, the FDA is providing recommendations regarding patient selection and device use,” William Maisel, MD, MPH, deputy center director for science, Center for Devices and Radiological Health at FDA, wrote in a letter last month.

The neurovascular stents are used to treat “wide-neck” aneurysms, defined as those with a neck width greater than 4 mm.

“Neurovascular stents for SAC provide important options for the treatment of wide-neck brain aneurysms, and their technology continues to evolve,” the letter notes. “However, these procedures are not without risks, and careful patient selection and proper device use are critical to ensure that the benefits to the patient outweigh the risk of treatment.”

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