Clinical Trial Enrollment Complete for Study of MIVI Q™ Revascularization System that Treats Acute Ischemic Stroke

EDEN PRAIRIE, Minn., May 3, 2023 ~ MIVI Neuroscience, Inc., a leader in the development of next-generation neurointerventional medical devices, has announced the completion of enrollment in its clinical trial to assess the safety and effectiveness of the Q™ Revascularization System for the treatment of acute ischemic stroke (EVAQ Trial).

The EVAQ Trial enrolled 121 patients at 17 centers globally. The data from this study will be used as part of an application to the U.S. Food and Drug Administration (FDA) for market clearance of the device in the United States.

The Q™ Revascularization System combines the MIVI Q™ Aspiration Catheter with the MIVI Super 90 Guide Catheter. It is designed to provide up to twice the aspiration power of traditional aspiration catheters and features simple and fast set up, prep, and operation.

Lucas Elijovich, MD, of Semmes-Murphey Neurologic Institute in Memphis, Tenn., and principal U.S. investigator said that while aspiration catheters are used in nearly every stroke treatment, their design has not significantly changed over the last decade. He added that The Q™ Aspiration Catheter is a novel design that delivers greater aspiration power without increasing the size of the catheter tip which may be especially advantageous in smaller vessels where large-bore catheters may not safely access and single-lumen catheters offer limited efficacy.

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Professor Christophe Cognard from Hôpital de Purpan in Toulouse, France, who is also a French principal investigator said that it is only through clinical research like EVAQ and innovative technologies like The Q™ Aspiration Catheter that stroke treatment will continue to advance. He expressed his pride at contributing to this study with his U.S colleagues and looked forward to its results.

Bob Colloton, CEO of MIVI Neuroscience expressed his gratitude towards all investigators for their contributions and dedication to this trial saying that its results will allow MIVI to expand their commercial footprint beyond their current European success into the important U.S market thus strengthening their foundation for future unique stroke-treatment devices.
Filed Under: Business

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