MIVI Neuroscience, Inc. announced that it has enrolled the first patient in the Food and Drug Administration approved Investigational Device Exemption EVAQ Clinical Study.
| EDEN PRAIRIE, Minn., Dec. 1, 2020 /PRNewswire/ -- MIVI Neuroscience, Inc. announced that it has enrolled the first patient in the Food and Drug Administration approved Investigational Device Exemption EVAQ Clinical Study. The procedure took place at Hôpital de Purpan in Toulouse, France. The study is a prospective, multi-center, single arm study to evaluate the MIVI Q™ Revascularization System for neurointervention in acute ischemic stroke (EVAQ Clinical Study). Study sites are located in France and The United States. The Q™ Revascularization System is based on the novel design of the Q™ Aspiration Catheter, in which a short, flexible catheter segment is mounted on a delivery wire. The design allows the Q™ Revascularization system to take advantage of the larger lumen of the Super 90 8F Guide Catheter for aspiration. Utilizing the larger guide catheter lumen in this way results in greater ingestion force which may improve revascularization rates. Professor Christophe Cognard of Hôpital de Purpan in Toulouse, France and the French Principal Investigator, commented, “Five years ago thrombectomy was proven to be a revolution in acute stroke management. However, there is still a need for technical advancements that can improve recanalization and decrease time. The MIVI Q System is very promising and we are pleased to confirm this first EVAQ enrollment.” U.S. EVAQ co-Principal Investigators Lucas Elijovich MD of Semmes-Murphey Neurologic Institute in Memphis, TN and Brian Jankowitz MD of Cooper University Healthcare in Camden, NJ added, “The Q catheter technology represents a substantial leap forward in improving aspiration based techniques for neurothrombectomy. We are looking forward to our first enrollments in the United States.” “We are pleased to announce this important milestone,” said Bob Colloton, CEO of MIVI Neuroscience, Inc. “Not only will the EVAQ Trial and the resulting data allow us to expand our commercial footprint, but it also provides a strong foundation for our future pipeline of unique stroke devices.” About MIVI Neuroscience MIVI Neuroscience, Inc. is focused on developing and commercializing superior clinical solutions for neurointerventional procedures. MIVI’s innovative product portfolio provides physicians with unique devices designed to improve patient outcomes in these procedures by reducing complications, shortening procedure times and expanding treatment to more patients. More information about MIVI can be found on the website www.mivineuro.com.
SOURCE MIVI Neuroscience |
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