Expanded Indication Approved in Europe for Stryker's Trevo Retriever to Treat Stroke Up to 24 Hours After Symptom Onset

May 9, 2018—Stryker announced that the company's Trevo Retriever has received European CE Mark approval as a frontline treatment for patients experiencing acute ischemic stroke up to 24 hours from symptom onset, increasing the treatment window by 18 hours.

In the company's press release, Professor Urs Fischer, MD, commented, "This is a big step forward, expanding the proportion of eligible patients for mechanical thrombectomy. For patients with a stroke of an unknown time of symptom onset or a wake-up stroke, a new therapeutic option is now available. However, mechanical thrombectomy should still be performed as quickly as possible, as numerous studies have shown that stroke patients treated early after symptom onset have a better outcome than patients treated late." Prof. Fischer is with the Department of Neurology, University Hospital of Bern, Switzerland.

In February 2018, Stryker announced approval of an expanded indication from the US Food and Drug Administration (FDA) as a front-line treatment for patients experiencing acute ischemic stroke up to 24 hours from onset.

According to the company, recent randomized clinical data from the Stryker-sponsored DAWN trial showed that patients presenting in the 6- to 24-hour window who meet specific imaging criteria and are treated with the Trevo Retriever are approximately four times as likely to be functionally independent at 90 days after stroke, compared with those treated with medical management alone. The DAWN trial was presented last May at ESOC 2017, the European Stroke Organization Conference in Prague, the Czech Republic.

Tudor Jovin, MD, stated in Stryker's announcement, "FDA clearance and CE Mark approval of the Trevo Retriever have effectively quadrupled the treatment window from 0 to 6 hours to 0 to 24 hours from time last seen well. Nonetheless, every minute still matters because in each individual patient, the earlier the blood flow is restored to the brain, the lower the resultant burden of permanent brain damage. Therefore, it is still imperative that all caregivers in the stroke pathway—from [emergency medical services] to emergency room physicians to stroke neurologists to interventionalists—continue to deliver the fastest and most workflow-efficient treatment of stroke." Dr. Jovin is with the University of Pittsburgh Medical Center in Pittsburgh, Pennsylvania.