Stryker (NYSE:SYK) said today that it won an expanded CE Mark indication in the European Union for its Trevo thrombectomy device as a front-line treatment for acute ischemic stroke patients for up to 24 hours from symptom onset.
The expanded indication lifts the previously cleared treatment window by 18 hours, according to the Kalamazoo, Mich.-based company, and follows a similar move in February by the FDA.
“Along with the expanded indication in the U.S., this expanded indication for Trevo in Europe marks a significant milestone in the treatment of stroke patients who suffer from this disease,” neurovascular president Mark Paul said in prepared remarks. “We believed this future was possible, which is why we invested in the Dawn trial. Through our dedication to help patients suffering from ischemic stroke, we are living our mission to make healthcare better.”
“This is a big step forward, expanding the proportion of eligible patients for mechanical thrombectomy,” added Dr. Urs Fischer of the University Hospital of Bern, Switzerland. “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.”
“FDA clearance and CE approval of the Trevo Retriever have effectively quadrupled the treatment window from zero-six hours to zero-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 EMS to emergency room physicians to stroke neurologists to interventionalists – continue to deliver the fastest and most workflow-efficient treatment of stroke,” noted Dr. Tudor Jovin of the University of Pittsburgh Medical Center.