Covidien, a medical device manufacturer based in Ireland, announced that it would start a new clinical trial for its Solitaire FR, a specialized snaking tool designed to retrieve clots from the brain.
While the company plans to continue with the trial as planned, Covidien already received regulatory approval for the device with the United States Food and Drug Administration. However, Covidien will continue the post-approval trial to gather additional clinical and research data on its Solitaire FR system.
According to information from the company, approximately 800 patients will be enrolled in its SWIFT PRIME trial. The first patient for the trial was enrolled at the University of Buffalo, and future patients will be enrolled at an additional 60 medical centers around the globe. The trial will explore the efficacy of treating acute ischemic stroke patients with an intravenous tissue plasminogen activator on its own and in combination with the Solitaire FR.
Jeffrey Saver is the director of the UCLA Geffen School of Medicine. In prepared remarks, he said, “The launch of the SWIFT PRIME trial is an important milestone in the evolution of stroke therapeutics.” He continued, “The goal of this international randomized trial is to demonstrate definitively the benefit of stent retriever therapy with the Solitaire FR Revascularization Device in patients with acute ischemic stroke.”