Covidien Opens Patient Enrollment for SWIFT PRIME Acute Ischemic Stroke Study

  Covidien Opens Patient Enrollment for SWIFT PRIME Acute Ischemic Stroke

New Clinical Trial Represents One of the Largest Global Studies to Examine the
        Effectiveness of Advanced Mechanical Treatment in Stroke Care

Business Wire

MANSFIELD, Mass. -- January 14, 2013

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: Busin ...

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.

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

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

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.

About Covidien

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 to learn more about our business.

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