FDA Okays Trevo Stent Retriever Out to 24 Hours After Stroke

Disclosures

February 15, 2018

The US Food and Drug Administration (FDA) has extended approval of use of the Trevo stent retriever device (Stryker Neurovascular) for the treatment of selected patients with ischemic stroke up to 24 hours after symptom onset.

The device was previously cleared for use in patients 6 hours after symptom onset. 

The expanded indication is based on the recently reported DAWN trial in which patients with ischemic stroke who had "clinical core mismatch" (a large clinical stroke score but a small core infarct size seen on imaging) treated with the device 6 to 24 hours after symptom onset had a greater chance of a better outcome than controls.

Of the 107 patients in the stent retriever group, 48% were functionally independent (modified Rankin Scale score of 0 to 2) at 90 days after their stroke compared with 13% of the 99 patients in the control group.

"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," said Carlos Peña, 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."

A statement from Stryker notes that "the Trevo Retriever is the first and only device indicated for treatment up to 24 hours, aligning with new AHA/ASA [American Heart Association/American Stroke Association] guidelines." The new guideline, released at the International Stroke Conference in January, includes selection criteria for patients to receive mechanical endovascular thrombectomy up to 24 hours after a stroke.

A second trial — DEFUSE 3 —  has also recently shown benefit of thrombectomy in patients presenting after 6 hours (up to 16 hours in this trial), but this National Institutes of Health–funded trial did not specify which stent retriever should be used; the choice was left to the discretion of the interventionalist.

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 thrombolytic therapy with tissue plasminogen activator (tPA) or for patients who did not respond to tPA therapy.

In 2016, the FDA allowed expanded marketing of the device for certain patients in addition to treatment with tPA if used within 6 hours of symptom onset. The new expanded indication increases the amount of time that the device can be used once the symptoms are present.

Risks associated with using 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, the FDA press release notes.

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