NeuroVasc’s Envi-SR Stent-Retriever Device Evaluated in Randomized Controlled Trial to Support Application for FDA Clearance

June 30, 2022—NeuroVasc Technologies, Inc. announced that the first patient has been treated in ENVI RCT, the NeuroVasc Envi-SR randomized controlled trial for endovascular treatment of ischemic stroke. The United States investigational device exemption clinical trial will evaluate the safety and efficacy of the Envi-SR, a stent-retriever device intended for the treatment of acute ischemic stroke to reduce disability by removing blood clots in patients with stroke caused by large vessel occlusion.

The results of the study will support an application to the FDA for clearance of the NeuroVasc Envi-SR device in the United States, where it is currently an investigational device, limited by federal law to investigational use. The Envi-SR has received CE Mark approval in Europe and is under investigation in China.

According to the company, the study is a prospective, multinational, randomized, parallel group-controlled, blinded, noninferiority trial to examine and compare clinical outcomes of patients being treated for acute ischemic stroke, as measured by modified Rankin Scale at 90 days posttreatment, and related performance characteristics of the NeuroVasc Envi-SR device and concurrent parallel control devices cleared by the FDA for treatment of ischemic stroke. The study will compare the next-generation Envi-SR with the Solitaire (Medtronic) and Trevo (Stryker) product families.

The initial procedure in the trial was performed by Nima Amin Aghaebrahim, MD, Interventional Neurologist and Primary Stroke Director at Baptist Stroke & Cerebrovascular Center in Jacksonville, Florida.

Vitor Mendes Pereira, MD, and Raul Nogueira, MD, are Coprincipal Investigators of the trial. Dr. Mendes Pereira is a neurosurgeon at St. Michael’s Hospital, University of Toronto, in Toronto, Canada. Dr. Nogueira is Director of the University of Pittsburgh Medical Center (UPMC) Stroke Institute and Professor of Neurology at UPMC in Pittsburgh, Pennsylvania.

“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,” commented Dr. Mendes Pereira in NeuroVasc’s press release.

Dr. Aghaebrahim added, “We are very proud to be participating in such trials to further advance the treatment we can offer to our patients.”

Ricardo Hanel, MD, PhD, Neurosurgeon and Comedical Director of Baptist Stroke & Cerebrovascular Center, further commented, “We are glad to get started on another landmark study, helping to bring new technology to our region and country.”