MicroVention Announces First Trial Enrollment In Their U.S. Clinical Trial Of Its New Dual-Layer Stent For Cerebral Aneurysm Flow Diversion
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(TM) flow diversion system (FRED(TM)-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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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.
Director, Corporate Communications
SOURCE MicroVention, Inc.