FDA expands treatment window for use of Trevo device in certain stroke cases
The U.S. Food and Drug Administration announced earlier that it has cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset, expanding the device's indication to a broader group of patients. The Trevo device was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in stroke patients who could not receive t-PA or for those patients who did not respond to t-PA therapy. In 2016, the FDA allowed expanded marketing of the device for certain patients in addition to treatment with t-PA if used within six hours of the onset of symptoms. Today's expanded indication increases the amount of time that the device can be used once the symptoms are present. The FDA granted premarket clearance of the Trevo device to Concentric Medical, a unit of Stryker.