Minnesota-based MIVI Neuroscience has enrolled the first patient in the Food and Drug Administration (FDA) approved Investigational Device Exemption (IDE) clinical study EVAQ.
EVAQ is a multi-centre, single arm trial, designed to evaluate the MIVI Q Revascularisation System for neurointervention in acute ischemic stroke patients.
The clinical trial is being conducted at different sites in France and the US. The first subject was treated at Hôpital de Purpan in Toulouse, France.
French principal investigator Christophe Cognard said: “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.”
MIVI designed Q Revascularization System based on Q Aspiration Catheter
The Q Revascularization System is designed based on the unique design of Q Aspiration Catheter, where a short, flexible catheter segment is mounted on a delivery wire.
The design enables the Q Revascularization system to tap on the larger lumen of the Super 90 8F Guide Catheter for aspiration.
According to MIVI, the utilisation of larger guide catheter lumen in such a way will lead to enhanced force ingestion, which could improve the revascularisation rates.
MIVI Neuroscience CEO Bob Colloton said: “We are pleased to announce this important milestone. 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.”
MIVI Neuroscience a medical device company, focused on developing and marketing clinical solutions intended for neuro-interventional procedures.
The company’s advanced product portfolio is said to provide physicians with devices that reduce complications, lower procedure times and expand the treatment to more patients.
