Stryker (NYSE:SYK) said today it won expanded FDA indications for its Trevo thrombectomy device, now cleared 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.
“The 24-hour indication opens the treatment window to patients whose stroke would previously have progressed until all the brain tissue surrounding the affected arteries was dead, leaving them with a life of significant disabilities. These patients now have a much better chance for an independent life without disability,” Dr. Raul Nogueira of Grady Memorial Hospital and Emory University said in a prepared statement.
“FDA clearance of the Trevo retriever has 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,” Dr. Tudor Jovin of the University of Pittsburgh Medical Center said in a prepared release.
Stryker said that the expansion is in line with recently updated guidelines from the American Heart Association and the American Stroke Association.
“This expanded indication for Trevo marks a significant milestone in the treatment of stroke patients who suffer from this catastrophic disease. We believed this future was possible, which is why we invested in the Dawn Trial. Through our efforts to help patients suffering from ischemic stroke, we are living our mission to make healthcare better,” Stryker neurovascular prez Mark Paul said in a press release.
Last November, Stryker released results from the Dawn trial of its Trevo thrombectomy device, touting significant effects even when used beyond six hours after stroke.