Covidien (NYSE:COV), a leading global provider of healthcare products, today announced the launch of a new study, SWIFT PRIME, which enrolled its first patient at the University at Buffalo. The new multi-center, randomized controlled trial will be one of the largest global studies to examine the adjunctive use of mechanical thrombectomy during the early stages of acute ischemic stroke onset.
Covidien's Solitaire FR Revascularization Device will be used in the SWIFT PRIME Study (Photo: Business Wire)
Acute ischemic stroke occurs when a clot in a blood vessel blocks blood supply to the brain. According to the American Heart Association, acute ischemic stroke is the leading cause of disability and the fourth most common cause of death in the United States. The SWIFT PRIME study will examine acute ischemic stroke patients treated with either intravenous tissue plasminogen activator (IV tPA) alone or IV tPA in combination with Covidien’s Solitaire™ FR Revascularization Device, an overlapping stent-based technology that provides substantially improved clinical outcomes to the previous generation of devices. The study will also include an extensive health economics analysis. “The launch of the SWIFT PRIME trial is an important milestone in the evolution of stroke therapeutics,” said Jeffrey L. Saver, MD, FAHA, FAAN, Professor of Neurology, Geffen School of Medicine at UCLA and Director, UCLA Comprehensive Stroke Center. “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.” Dr. Saver is co-leading the study with Elad I. Levy, MD, FACS, FAHA, Professor of Neurosurgery and Radiology, University at Buffalo and Director of Interventional Stroke Services, Director of Endovascular Neurosurgery Fellowship Education and Co-Director for Stroke, Kaleida Health.
Ikaria, which focuses on therapies for critically ill infants, is privately owned by a group led by Madison Dearborn Partners. Buyer Mallinckrodt specializes in diagnostic radiology and pain management.