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Clot Retrieval Device for Stroke Now Cleared for Use Up to 24 Hours
The FDA announced that it has cleared a clot retrieval device for treatment of certain patients with stroke for use up to 24 hours after onset of symptoms.
The device (Trevo, Concentric Medical/Stryker Neurovascular) was first cleared by the FDA in 2012 to remove a blood clot and restore blood flow in patients with stroke who could not receive tissue plasminogen activator (tPA) or those who did not respond to it, and the device received an expanded indication in 2016 for use within 6 hours of onset in certain patients with stroke who received tPA, according to a press release issued by the agency.
The device is now cleared for use as an initial therapy for strokes due to blood clots to reduce paralysis, speech difficulties and other stroke disabilities and as an addition to treatment with tPA, the agency stated in the release.
According to the release, the new indication was granted based on the results of the DAWN trial comparing 107 patients assigned the Trevo device and medical management with 99 patients assigned medical management alone.
As Cardiology Today’s Intervention previously reported, the results of the study showed 48.6% of patients treated with the device were functionally independent 3 months after stroke, compared with 13.1% of patients assigned medical management alone. The number needed to prevent one severe disability was 2.8.
The FDA stated that 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.
“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, director of the division of neurological and physical medicine devices at the FDA’s Center for Devices and Radiological Health, said in the release. “Health care providers and their patients now have better tools for treating stroke and potentially preventing long-term disability.”
Disclosure: Peña reports he is an employee of the FDA.