The FDA on Feb. 15 announced Stryker’s Trevo Retriever clot-removal device can be used up to 24 hours after stroke onset, mirroring the American Heart Association and American Stroke Association’s recently updated guidelines expanding the window for mechanical thrombectomy from 6 to 24 hours.
The Trevo device was previously only indicated for up to six hours after the first signs of stroke.
In its news release on the expanded indication, the FDA cited results of the DAWN trial, which compared 107 patients treated with the stent retriever and medical management to 99 patients who received only medical management. About 48 percent of the patients treated with the device in the 6 to 24-hour window were functionally independent at three months, compared to 13 percent of patients treated with medical management alone.
“Expanding the treatment window from 6 to 24 hours will significantly increase the number of stroke patients who may benefit from treatment,” said Carlos Pena, PhD, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health. “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”
According to Stryker, the Trevo Retriever is the first thrombectomy device to receive FDA clearance for use that long after symptom onset. Physicians thread the device through the femoral artery to a blocked artery in the brain, where they can grab a blood clot and remove it from the body.
Risks associated with the Trevo system, according to the FDA, include a failure to retrieve the blood clot, embolization to other territories in the brian, arterial dissections, vascular perforations and access-site complications at the femoral artery.
Despite the FDA’s approval for later use of the device, it is important to remember stroke intervention is time-sensitive, said DAWN principal investigator Tudor Jovin, MD.
“Every minute still matters because in each individual patient, the earlier the blood flow is restored to the brain, the lower the resultant burden of permanent brain damage,” said Jovin, co-director of endovascular therapy at University of Pittsburgh Medical Center.
“Therefore, it is still imperative that all caregivers in the stroke pathway—from EMS to emergency room physicians to stroke neurologists to interventionalists—continue to deliver the fastest and most workflow-efficient treatment of stroke.”