FDA Expands Treatment Window for Trevo Stent Retriever
The broader indication is based on the results of the DAWN trial, which has already changed stroke guidelines.
The Trevo stent retriever (Stryker Neurovascular) can now be used up to 24 hours after the onset of symptoms in patients with acute ischemic stroke caused by large-vessel occlusion, the US Food and Drug Administration (FDA) announced today.
The device had already been approved for use within 6 hours of symptom onset in patients who had already received IV thrombolytics or within 8 hours of symptom onset in patients who were ineligible for or did not respond to IV thrombolytics, but last May the DAWN trial showed that thrombectomy with the device is effective out to as long as 24 hours.
DAWN enrolled patients presenting from 6 to 24 hours after stroke onset who had a mismatch between the severity of the clinical deficit and the infarct volume as assessed by diffusion-weighted MRI or perfusion CT. Those who were treated with the Trevo device in addition to standard care were more likely to be functionally independent at 3 months than were those who received standard care alone (49% vs 13%).
The FDA’s expansion of Trevo’s indication comes after guidelines from the American Heart Association/American Stroke Association have already been changed to incorporate the DAWN results.
FDA. FDA expands treatment window for use of clot retrieval devices in certain stroke patients. Published and Accessed on February 15, 2018.