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 FREDT flow diversion system (FREDT-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 FREDT 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 FREDT 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 FREDT 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 FREDT 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 FREDT 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 FREDT 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.