Stryker's Trevo Retriever Now Indicated for Treating Stroke Up to 24 Hours From Symptom Onset
Stryker has announced that its Trevo Retriever device has received an expanded indication from the US Food and Drug Administration (FDA) as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from onset.
According to Stryker, the Trevo Retriever is the first thrombectomy device to receive FDA approval to reduce disability in patients up to 24 hours after onset of symptoms, which increases the treatment window by 18 hours. Until this expanded indication, mechanical thrombectomy devices had only been approved for use up to 6 hours from symptom onset.
"The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities," commented Raul Nogueira, MD, of Grady Memorial Hospital and Emory University in the company’s announcement. "These patients now have a much better chance for an independent life without disability."
Stryker obtained FDA approval for this expanded indication from recent radomized clinical data from their sponsored DAWN trial, which demonstrated patients presenting in the 6- to 24-hour window who meet specific imaging criteria and are treated with the Trevo Retriever are almost four times as likely to be functionally independent at 90 days poststroke, compared with those treated with medical management alone.
According to the company’s announcement, the expanded indication is in line with recent guideline updates from American Heart Association and American Stroke Association recommending stent retrievers as the standard of care for stroke patients experiencing a large artery blockage.
The device has been approved for use in the United States since 2012.