TUSTIN, Calif., July 22, 2013 /PRNewswire/ -- MicroVention, Inc.,
a wholly owned subsidiary of Terumo Corporation, announced earlier
last week that they successfully completed their first enrollment
in a multi-center, prospective, pivotal U.S. clinical trial to
demonstrate the safety and efficacy of its FRED™ flow diversion
system (FRED™-Flow Re-Direction Endoluminal
Device) for treating intracranial aneurysms. Intracranial
aneurysms are an abnormal, outward bulging of an artery in the
brain caused by weakness in the arterial wall.
The FRED™ system is currently approved (CE marked) in European
countries and several other international markets, where clinical
cases have already been performed.
The first patient was enrolled by Aquilla S. Turk, D.O., Director of
Neurointerventional Division and Principal Investigator at the
Medical University of South Carolina,
who commented, "The FRED™ system was successfully deployed to treat
a recurrent ophthalmic artery aneurysm that had previously been
treated with embolic coils, and the flow diverter device provided
the best option for long-term treatment durability. The FRED™
system was easy to deliver and we believe it represents a step
forward in flow diversion stent technology."
Cameron McDougall, M.D., FRCSC,
Chief, Endovascular Neurosurgery at the Barrow Neurological
Institute in Phoenix, Arizona and
Primary Investigator for the multicenter U.S. study commented, "I
am very pleased to see the FRED™ system trial officially
underway. I want to thank Dr. Turk and his staff at MUSC for
their excellent work in successfully treating our first
patient. I would also like to acknowledge the MicroVention
team for all they have done to get us to this point. It is
exciting to see this study move forward, understanding that we have
a chance to provide patients with improved treatment options."
Richard Cappetta, President and
CEO of MicroVention, Inc. noted that, "The FRED™ system study is
intended to provide clinical evidence that MicroVention's
next-generation flow diverter device can effectively treat these
difficult aneurysms, and offer new endovascular treatment options
for physicians. The enhanced visibility and ease of delivery and
deployment, key features of the FRED™ system device, will hopefully
result in improved clinical outcomes."
A description of this clinical trial can be found at
http://clinicaltrials.gov; Study Number: NCT01801007, as required
by U.S. Law.
About the FRED™ system
The Flow Re-Direction
Endoluminal Device (FRED) system is the next generation flow
diversion device intended for the treatment of intracranial
aneurysms. The FRED™ system is an innovative, uniquely
paired, integrated dual-layer (stent-within-a-stent) self-expanding
nitinol braided design, which is simultaneously deployed by a
single operator through a .027 (0.69 mm) inner diameter Headway™ 27
microcatheter. The higher radial force outer stent, along
with the low porosity-high metal surface area inner stent, unite to
provide superb ease of use, enhanced stent opening, improved vessel
apposition and fluoroscopic visibility, to help reduce and redirect
blood flow into the aneurysm sac. The FRED™ system offers
additional benefits over first generation flow diversion devices,
by its ability to be partially deployed, retrieved and accurately
repositioned/redeployed, without the need for a torque
device.
About MicroVention, Inc.
MicroVention, Inc. is a U.S.
subsidiary of Terumo Corporation with its corporate headquarters in
Tustin, California, and
manufacturing and administrative facilities in Santa Ana and Aliso
Viejo, California, and San
Jose, Costa Rica. MicroVention is a developer,
manufacturer and marketer of innovative neuroendovascular
technologies for the treatment of vascular diseases in small
vessels. MicroVention products are sold throughout the world
in more than 62 countries. For more information, visit
www.microvention.com.
About Terumo Corporation
Tokyo-based Terumo Corporation is one of the
world's leading medical device manufacturers with $4 billion in sales and operations in more than
160 nations. Founded in 1921, the company develops,
manufactures and distributes world-class medical devices including
products for use in cardiothoracic surgery, interventional
procedures and transfusion medicine; the company also manufactures
a broad array of syringe and hypodermic needle products for
hospital and physician office use. Terumo contributes to
society by providing valued products and services to the health
care market and by responding to the needs of health care providers
and the people they serve. Terumo Corporation's shares are
listed on the first section of the Tokyo Stock Exchange (No. 4543,
Reuters symbol <4543.T>, or Bloomberg 4543: JP) and is a
component of the Nikkei 225, Japan's leading stock index.
Media Contact:
Cathy
Demyanovich
Director, Corporate Communications
MicroVention. Inc.
800-990-8361
714-247-8000
SOURCE MicroVention, Inc.