MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of Its New Dual-Layer Stent For Cerebral Aneurysm

MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of
        Its New Dual-Layer Stent For Cerebral Aneurysm Flow Diversion

PR Newswire

TUSTIN, Calif., July 22, 2013

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

The FRED™ system is currently approved (CE marked) in European countries and
several other international markets, where clinical cases have already been

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

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.

SOURCE MicroVention, Inc.

Website: http://www.microvention.com
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