NeuroVasc Technologies recently announced that the first patient has been treated in its US investigational device exemption (IDE) clinical study, the ENVI randomised controlled trial (RCT). The ENVI RCT will evaluate the safety and efficacy of the company’s ENVI-SR stent retriever, which is intended for the treatment of acute ischaemic stroke to reduce disability by removing blood clots in patients with large vessel occlusion (LVO) stroke.
“By enrolling this first patient in this trial, we are taking an important step toward building evidence to support the clinical use of this novel, next-generation stroke device,” said Vitor Pereira (St Michael’s Hospital, Toronto, Canada), who is a co-principal investigator along with Raul Nogueira (University of Pittsburgh, Pittsburgh, USA).
The study is a prospective, multinational, randomised, parallel group-controlled, blinded, non-inferiority trial designed to examine and compare clinical outcomes of patients being treated for acute ischaemic stroke as measured by modified Rankin Scale (mRS) score at 90 days post-treatment, and related performance characteristics, of the NeuroVasc ENVI-SR and concurrent parallel control devices currently cleared by the US Food and Drug Administration (FDA) for treatment of ischaemic stroke.
“We are very proud to be participating in such trials to further advance the treatment we can offer to our patients,” said Nima Amin Aghaebrahim (Baptist Stroke and Cerebrovascular Center, Jacksonville, USA), who performed the first procedure in the ENVI RCT. “We are glad to get started on another landmark study, helping to bring new technology to our region and country,” added Ricardo Hanel (Baptist Stroke and Cerebrovascular Center, Jacksonville, USA).
The study will compare the next-generation ENVI-SR stent retriever with the Solitaire (Medtronic) and Trevo (Stryker) product families. As per a NeuroVasc press release, its results will support an application to the FDA for clearance of the NeuroVasc ENVI-SR device in the USA, further expanding the company’s commercial footprint and providing a strong foundation for its future pipeline of game-changing neurovascular technologies.