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 p
|SOURCE MicroVention, Inc.|
Copyright©2012 PR Newswire.
All rights reserved