A thrombus retrieval device for use in patients experiencing an acute ischemic stroke has been cleared for marketing in the United States by the Food and Drug Administration, the manufacturer announced on Aug. 13.
The device will be marketed as the "Trevo Pro Retriever," according to the statement issued by Stryker Neurovascular.
In May, the company announced the results of the TREVO 2 study, a randomized, clinical trial that compared the Trevo device with another Stryker device, the Merci Retriever, in patients experiencing an acute ischemic stroke. The inclusion criteria were patients aged 18-85 years presenting with clinical signs and symptoms consistent with an acute ischemic stroke, who had either failed; tissue plasminogen activator (TPA) therapy or in whom TPA was contraindicated, according to the description of the study.
The postprocedure revascularization rate was 92% among patients randomized to treatment with the Trevo device, compared with 77% among those treated with the Merci Retriever device, a significant difference, according to the statement announcing the device’s premarket notification clearance. Performance measures that included shorter hospital stays and improvement in the National Institutes of Health Stroke Scale also favored the Trevo Pro Retriever device, the statement said.
The device was developed by Concentric Medical, which was acquired by Stryker in October 2011.