FDA sends letter to healthcare providers on neurovascular stents

Editor's Note

The Food and Drug Administration (FDA) on May 8 sent a letter to healthcare providers that included recommendations on the use of neurovascular stents for stent-assisted coiling in the treatment of unruptured brain aneurysms.

The FDA has received reports associated with these devices that suggest events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection factors. These include patients with serious comorbidities resulting in a reduced life expectancy or who were intolerant to anticoagulation or antiplatelet therapy.