The Stryker product is now cleared to be used up to 24 hours after symptom onset.
The US Food and Drug Administration (FDA) today approved the expanded use of the Trevo clot retrieval device for the treatment of selected patients with an ischemic stroke up to 24 hours after onset of symptoms. It is the only such device cleared to operate in that window.
The Stryker Neurovascular product was originally cleared in 2012 by the FDA for the removal of blot clots to restore blood flow in patients with stroke that could not receive or did not respond to tissue plasmogen activator (t-PA) therapy. In 2016, the administration cleared the indication to expand to include certain patients in addition to t-PA therapy within 6 hours of symptom onset.
According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the U.S. and is a major cause of serious disability for adults. About 795,000 people in the U.S. have a stroke each year. Ischemic strokes represent about 87 percent of all strokes.
“Time is critical following the onset of stroke symptoms. Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” Carlos Peña, PhD, the director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in a statement. “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”
The decision was made based on data from the DAWN clinical trial of 206 patients treated with either the device (n = 107) or with only medical management (n = 99). The trial revealed that 48% of the patients treated with the device were functionally independent within 3 months post stroke, compared with 13% of patients in the medical management group.
"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, MD, 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."
The device was also used in the DEFUSE 3 study, aiding in the recent updates to the America Heart Association/American Stroke Association guidelines, which recommends stent retrievers such as the Stryker product. Between the trials—DAWN and DEFUSE 3—the largest cohort of data for a single device was collected.
The DAWN study, "Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct," was published in the New England Journal of Medicine.
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