New Clinical Trial Represents One of the Largest Global Studies to Examine the Effectiveness of Advanced Mechanical Treatment in Stroke Care
MANSFIELD, Mass. - Monday, January 14th 2013
(BUSINESS WIRE/ ME NewsWire)-- 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.
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.
Dr. Levy added, "SWIFT PRIME is the first multi-center prospective study that studies brain physiology when selecting patients for stent retriever treatment. We hope this study will help better understand the patient population that most benefits from thrombolysis combined with mechanical thrombectomy.”
The study may enroll up to 800 patients across 60 centers globally. Prof. Hans-Christoph Diener MD, Ph.D., Professor of Neurology and Chairman of the Department of Neurology at the University of Essen, Chairman of the Essen Stroke Center and co-chair of the Neurological Rehabilitation Unit, Department of Neurology, University Hospital Essen in Germany and Prof. Vitor Mendes Pereira, MD, MSc, Director of Interventional Neuroradiology Division (Médecin Adjoint Responsible d’Unité), Service de Neuroradiologie, University Hospital of Geneva in Switzerland will serve as the European Principal Investigator and European Interventional Principal Investigator, respectively.
"Technological innovation in mechanical thrombectomy represents one of the most promising new developments in stroke treatment,” said Dr. Mark Turco, Chief Medical Officer, Covidien Vascular Therapies. "The Solitaire FR, an advanced stroke device, shows substantial improvements in outcomes over previous mechanical thrombectomy treatments. The SWIFT PRIME study is an important step in assessing both the clinical and economic value of our newest innovation in this area, underscoring Covidien’s commitment to the advancement of stroke care. We also look forward to the insights that the study will provide into critical components of stroke treatment, such as time and imaging.”
The Solitaire FR device that will be used in the trial received U.S. FDA 510(k) marketing clearance in 2012 and CE Mark approval in 2009.
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2012 revenue of $11.9 billion, Covidien has 43,000 employees worldwide in 70 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.