Mivi Neuroscience Completes Enrollment in EvaQ Trial of Q Revascularization System

Mivi Neuroscience, Inc. (Eden Prairie, Minnesota), a developer of neurointerventional medical devices, announced that it has completed enrollment in the EvaQ clinical trial.

According to the company, the EvaQ trial is being conducted to assess the safety and effectiveness of the company’s Q revascularization system for the treatment of acute ischemic stroke. The trial enrolled 121 patients at 17 centers globally.

Data from the study will be used as part of an application to the FDA for market clearance of the device in the United States. Mivi Neuroscience’s Q revascularization system combines the company’s 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 setup, prep, and operation, stated the company.

The study’s United States Principal Investigator is Lucas Elijovich, MD, of Semmes-Murphey Neurologic Institute in Memphis, Tennessee. Professor Christophe Cognard, MD, of Hôpital de Purpan in Toulouse, France, is the trial’s French Principal Investigator.

“While aspiration catheters are used in nearly every stroke treatment, their design has not significantly changed over the last decade,” commented Dr. Elijovich in the company’s press release. “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.”

Prof. Cognard 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 United States colleagues and look forward to the results of the trial.”

Also in the press release, Bob Colloton, CEO of Mivi Neuroscience, stated, “We are grateful to all of our investigators for their contributions and dedication to the EvaQ trial. The results of this study will allow Mivi to expand our commercial footprint beyond our current European success and into the important United States market, strengthening the foundation for future unique stroke treatment devices.”

Neurointerventional news coverage produced in conjunction with Endovascular Today.