United States Pivotal Trial Begins of MicroVention's FRED Stent for Cerebral Aneurysm Flow Diversion

July 22, 2013—MicroVention, Inc. (Tustin, CA), a wholly owned subsidiary of Terumo Corporation (Tokyo, Japan), announced initiation of enrollment in a multicenter, prospective, pivotal clinical trial in the United States to demonstrate the safety and efficacy of the company's flow diversion system called FRED (flow-redirection endoluminal device), for treating intracranial aneurysms. The FRED system has received CE Mark approval for use in Europe and several other international markets.

Cameron McDougall, MD, Chief of Endovascular Neurosurgery at the Barrow Neurological Institute in Phoenix, Arizona, serves as Primary Investigator for the study. Aquilla S. Turk, DO, Director of Neurointerventional Division and Principal Investigator at the Medical University of South Carolina (MUSC), enrolled the first patient in the study.

“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,” Dr. Turk commented in the company's press release. “The FRED system was easy to deliver and we believe it represents a step forward in flow diversion stent technology.”

According to MicroVention, the FRED system is the company's next-generation flow diversion device intended for the treatment of intracranial aneurysms. The FRED system incorporates a paired, integrated dual-layer (stent-within-a-stent) self-expanding nitinol braided design. The device is deployed by a single operator through a .027-inch (0.69 mm) inner diameter Headway 27 microcatheter (MicroVention). The higher-radial force outer stent and the low-porosity, high metal surface area inner stent aims to provide ease of use, enhanced stent opening, improved vessel apposition, and fluoroscopic visibility to help reduce and redirect blood flow into the aneurysm sac. Additionally, new features of the next-generation system include its ability to be partially deployed, retrieved, and accurately repositioned/redeployed, without the need for a torque device.