FDA Approves Indication for Stryker’s Trevo Retriever As Initial Treatment for Ischemic Stroke
September 6, 2016—Stryker announced that the US Food and Drug Administration (FDA) expanded the indication for the company’s Trevo Retriever for initial treatment to reduce disability in patients experiencing acute ischemic stroke.
Per the original indication, Trevo Retrievers are intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV tPA) or who fail IV tPA therapy are candidates for treatment.
In the expanded indication, Trevo Retrievers are also indicated to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received IV tPA for acute ischemic stroke. Patients should be able to start treatment within 6 hours of symptom onset.
According to Stryker, randomized clinical data using the Trevo Retriever along with IV tPA show that patients are almost twice as likely to be functionally independent at 90 days after a stroke compared to medical management alone. These data led to Trevo Retriever receiving the first FDA clearance for a thrombectomy device to significantly reduce disability in patients with ischemic stroke. This clearance for first-line use expands treatment with Trevo to a broader group of patients.
Based on the clinical evidence, the Trevo Retriever is also included in the American Heart Association’s 2015 stroke care guideline update, in which stent retrievers are now recommended as the standard of care for stroke patients experiencing a large artery blockage. In June 2015, the updated guideline was published online by William J. Powers, MD, et al in Stroke.
In Stryker’s announcement, Amrou Sarraj, MD, commented, “This new and unique indication for Trevo, as initial therapy for acute ischemic stroke with large vessel occlusions, has the potential to help hundreds of thousands of stroke patients. These patients now have a significantly better chance for an independent life without disability.”
Dr. Sarraj continued, “So many patients with major ischemic stroke due to large vessel occlusions still go untreated today, largely ending up with a devastating long-term disability. The FDA clearance of the Trevo Retriever as a front-line treatment to reduce disability reinforces the importance that all caregivers in the stroke pathway—from emergency medical services to emergency room physicians to neurologists to interventionists—continue to come together to deliver fast and efficient treatment of stroke.” Dr. Sarraj is Assistant Professor of Neurology and Vascular Neurology Fellowship Program Director at the University of Texas Health Science Center in Houston, Texas.
In the FDA’s announcement, Carlos Peña, PhD, Director of the Division of Neurological and Physical Medicine Devices at the FDA’s Center for Devices and Radiological Health, stated, “This is the first time FDA has allowed the use of these devices alongside tPA, which has the potential to help further reduce the devastating disabilities associated with strokes compared to the use of tPA alone. Now health care providers and their patients have another tool for treating stroke and potentially preventing long-term disability.”