The New England Journal of Medicine has published the results of Kalamazoo-based medical technology company Stryker Corp.’s DAWN trial, which researched the treatment of late window and wake-up stroke patients with mechanical thrombectomy.
Stryker’s Trevo Retriever is a small stent-shaped medical device attached to a thin wire, which is inserted via a minimally invasive procedure. Using an X-ray, the physician navigates the retriever from the femoral artery in the upper leg to the blocked artery in the brain, where its designed to capture and remove the clot.
Currently, less than one in 10 ischemic stroke patients receives thrombectomy, due in part to a lack of scientific evidence to support treatment beyond six hours. The DAWN Trial’s results, however, have the potential to change the paradigm of care for stroke patients worldwide.
Sponsored by Stryker, the DAWN Trial was designed to evaluate functional outcomes at 90 days in stroke patients treated with mechanical thrombectomy using the Trevo Retreiver, compared to those receiving therapy alone. Patients were screened for inclusion if they had a stroke that started within six to 24 hours, or a stroke with an unknown time of onset, which provides a significantly longer treatment window than is currently cleared for thrombectomies.
“The results of the DAWN Trial offer the first level-one evidence of significant reduced disability in patients who present in the late time window,” says Mark Paul, president of Stryker’s neurovascular division. “However, best outcomes are achieved when patients are treated as quickly as possible, requiring increased patient awareness, EMS outreach, and hospital infrastructure to be in place.”
Originally cleared by the Food and Drug Administration in 2012, the Trevo Retriever was the only mechanical thrombectomy devise used in the DAWN Trial.