The EVAQ Trial enrolled 121 patients at 17 centers globally and data from the 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 MIVI Q Revascularization System. (Credit: PR Newswire/ MIVI Neuroscience)
MIVI Neuroscience, innovator of next-generation neuro interventional medical devices, today announced that it has completed enrollment in the company’s 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. Data from the 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. The System is designed to provide up to twice the aspiration power of traditional aspiration catheters and features simple and fast set up, prep, and operation.
According to Lucas Elijovich, MD, of Semmes-Murphey Neurologic Institute in Memphis, Tenn., and principal U.S. investigator, “While aspiration catheters are used in nearly every stroke treatment, their design has not significantly changed over the last decade. The Q Aspiration Catheter is a novel design that delivers greater aspiration power without increasing the size of the catheter tip. This may be especially advantageous in smaller vessels, where large-bore catheters may not safely access and single-lumen catheters offer limited efficacy.”
Professor Christophe Cognard of Hôpital de Purpan in Toulouse, France, the French principal investigator added, “It is only through clinical research like EVAQ and innovative technologies like the Q Aspiration Catheter that stroke treatment will continue to advance. We’re proud to contribute to the study with our U.S. colleagues and look forward to the results of the trial.”
“We are grateful to all of our investigators for their contributions and dedication to the EVAQ trial,” said Bob Colloton, CEO of MIVI Neuroscience. “The results of this study will allow MIVI to expand our commercial footprint beyond our current European success and into the important U.S. market, strengthening the foundation for future unique stroke-treatment devices.”
Source: Company Press Release