MIVI Neuroscience has recently confirmed that the first patient has been enrolled in the Investigational Device Exemption EVAQ Clinical Study, which has been approved by the U.S. FDA. The enrollment was done in Toulouse, France at Hôpital de Purpan. The trial is a nulti-center, prospective single arm strudy for evaluating the MIVI Q Revascularization System targeting neurointervention in acute ischemic stroke.
The study sites for this EVAQ clinical trial are situated in the U.S. and France. Based on the innovative design of the Q Aspiration Catheter, the Q Revascularization System is able to leverage the larger lumen of the Super 90 8F Guide Catheter for aspiration. The Q Aspiration Catheter comprises a short and flexible catheter segment that is mounted on a delivery wire. By using the larger guide catheter lumen in this manner allows for a higher ingestion force, possibly improving revascularization rates.
MIVI Neuroscience CEO, Bob Colloton stated that the result data from EVAQ study will not only enable expansion of the company’s commercial footprint, but also deliver a strong foundation for its future pipeline comprising unique stroke devices.
Aiming to develop and commercialize advanced clinical solutions for neurointerventional procedures, MIVI Neuroscience, Inc. boasts of novel products enabling physicians to use unique devices. These devices are designed for improving patient outcomes in procedures through the reduction of complications, augmenting treatment access and reducing procedure times.
Christophe Cognard, Professor at Hôpital de Purpan in Toulouse and also the French Principal Investigator for the study, noted that thrombectomy was shown to be a revolutionary solution in acute stroke management five years back. There is, however, still the need to achieve technical developments for enhancing recanalization and decrease time. Cognard believes the MIVI Q System to be a promising solutions and also appreciated the first enrollment in EVAQ trial.