NeuroVasc Technologies, Inc. today announced that the first patient has been treated in its US IDE Clinical Trial, ENVI RCT – NeuroVasc Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke. This trial will evaluate the safety and efficacy of the NeuroVasc ENVI™-SR, a stent-retriever intended for the treatment of acute ischemic stroke to reduce disability by removing blood clots in patients with stroke due to large vessel occlusion.
“By enrolling this first patient in this trial, we’re taking an important step toward building evidence to support the clinical use of this novel, next generation stroke device,” shared Vitor Mendes Pereira, MD, a neurosurgeon with St. Michael’s Hospital, University of Toronto, who is a co-Principal Investor along with Raul Nogueira, MD, director of the University of Pittsburgh Medical Center (UPMC) Stroke Institute and professor of neurology at UPMC.
The study is a prospective, multinational, randomized, parallel group-controlled, blinded, non-inferiority trial to examine and compare clinical outcomes of patients being treated for acute ischemic stroke, as measured by Modified Rankin Scale (mRS) at 90 days post treatment, and related performance characteristics of the NeuroVasc ENVI™-SR and concurrent parallel Control Devices currently cleared by the U.S. FDA for treatment of ischemic 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, MD, interventional neurologist and primary stroke director at Baptist Stroke & Cerebrovascular Center in Jacksonville, Florida, who performed the procedure.
The study will compare the next generation NeuroVasc ENVI™-SR with the Solitaire™ (Medtronic) and Trevo® (Stryker) product families.
“Partnering with the neurointerventional community in the U.S. offers us a great opportunity to investigate our novel technology with the view to improving the treatment of patients experiencing acute ischemic stroke around the world. We are proud of the NeuroVasc team in reaching this milestone,” said Michael Losordo, NeuroVasc chief operating officer.
As populations age, the number of strokes is also on the rise. According to the World Health Organization, stroke is the second leading cause of death worldwide. An acute ischemic stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. When that happens, brain cells begin to die in minutes and prompt treatment is crucial. Early action can reduce brain damage and potential outcomes such as physical disability and death.
“We are glad to get started on another landmark study, helping to bring new technology to our region and country,” said Ricardo Hanel, MD, PhD, neurosurgeon and co-medical director of Baptist Stroke & Cerebrovascular Center.
The results of the study will support an application to the U.S. FDA for clearance of the NeuroVasc ENVI™-SR device in the US, further expanding our commercial footprint and providing a strong foundation for NeuroVasc’s future pipeline of game-changing neurovascular technologies.
About the ENVI RCT – NeuroVasc Envi™-SR Randomized Controlled Trial for Endovascular Treatment of Ischemic Stroke: The ENVI RCT trial is the first prospective clinical trial in Ischemic Stroke which is an international, multicenter, randomized, controlled clinical trial to assess the effectiveness and safety of the NeuroVasc Envi™-SR mechanical thrombectomy device for the restoration of blood flow in ischemic stroke. The trial is planned to enroll approximately 560 subjects in about 30 clinical centers across the US, Canada, and Europe. The study is being overseen by Vastrax, Inc., the world’s leading full-service vascular clinical research organization (CRO).
The NeuroVasc ENVI™-SR is a next generation clot retrieval device for use in patients experiencing acute ischemic stroke. NeuroVasc ENVI™-SR was developed from the start as a stent-retriever, and the unique articulating segmental design allows the device to remain open under tension. The NeuroVasc ENVI™-SR was developed with the support of physicians from Canada, China, Japan, France, the United Kingdom, and the United States. It has received CE Mark and is currently under investigation in China. The NeuroVasc Envi™-SR is an investigational device, limited by federal (or United States) law to investigational use.