FDA Expands Treatment Window for Blood Clot Retrieval Device

The FDA cleared the use of the Trevo clot retrieval device to treat certain stroke patients up to 24 hours after symptom onset – an increase from the original clearance of up to six hours after symptom onset.

“Time is critical following the onset of stroke symptoms,” said Carlos Peña, PhD, director of the Division of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health. “Expanding the treatment window from six to 24 hours will significantly increase the number of stroke patients who may benefit from treatment.”

The Trevo device is approved for use as an initial therapy for ischemic strokes to help reduce paralysis, speech difficulties, and other stroke-related disabilities. In 2012, the FDA initially approved the device to remove blood clots and restore blood flow in stroke patients who could not receive tissue plasminogen activator (t-PA) therapy or for those who did not respond to this treatment. In 2016, the FDA expanded the window of treatment to within six hours of symptom onset when used with t-PA.

The decision to further expand the treatment window was based on clinical trial data comparing 107 patients treated with the Trevo device and medical management versus 99 patients treated only with medical management. Approximately 48 percent of patients treated with the Trevo device were functionally independent (ranging from no symptoms to slight disability) three months post-stroke, compared with 13 percent of patients who were treated with medical management alone.

AEs associated with the device include a failure to retrieve the blood clot, embolization to new territories in the brain, arterial dissections and vascular perforations, and access site complications at the femoral artery entry point.

Source: U.S. Food and Drug Administration press release, February 15, 2018.