Stryker has received European clearance to use its stroke device Trevo Retriever up to 24 hours after the onset of symptoms. The CE mark comes three months after the FDA signed off on the expanded indication.
Gaining the back-to-back regulatory clearances positions Stryker to extend the treatment window for stroke patients. In the past, doctors only used Retriever and other thrombectomy devices to remove blood clots in the six hours after a patient suffered a stroke. Now, using Retriever, doctors can perform thrombectomies for up to 24 hours after 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," Raul Nogueira, M.D., of Grady Memorial Hospital and Emory University, said in a statement. "These patients now have a much better chance for an independent life without disability."
Stryker secured the expanded indication on the strength of data from its DAWN trial. The study assessed the effect of Retriever on patients who appeared to have malfunctioning but salvageable brain tissue.
Almost half of the 107 patients who received Retriever and standard of care in the 6 to 24 hours after suffering a stroke were functionally independent 90 days later, as compared to 13% in the control arm. The data showed thrombectomy is viable for another group of patients while still suggesting it is preferable to intervene sooner.
By running the trial and securing the clearances, Stryker has furthered its track record of expanding Retriever's label. Stryker brought the device to market in the U.S. in 2012 before going on to get the label expanded to cover reducing disability in 2016.