Pivotal trial will assess use of the device for blood clot removal in strokes
IRVINE, Calif., September 23, 2021--(BUSINESS WIRE)--NeuroVasc Technologies, Inc. today announced that the first patient has been treated in a Chinese Pivotal Randomized Controlled Trial to evaluate the safety and efficacy of the ENVI™-SR Mechanical Thrombectomy System (ENVI™-SR), a stent-retriever for the removal of blood clots in patients with acute ischemic stroke due to large vessel occlusion. The procedure was performed by Dr. Zhaoshuo Li, associate professor of Stroke Center led by professor Li Tianxiao, at the HeNan Province People’s Hospital, China.
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The ENVI™-SR Mechanical Thrombectomy System (ENVI™-SR), a stent-retriever being developed by NeuroVasc Technologies for the removal of blood clots in patients with acute ischemic stroke due to large vessel occlusion. Visit www.neurovasctechnologies.com for more information (Photo: Business Wire)
The study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of the mechanical thrombectomy system for endovascular treatment of acute ischemic stroke. The study will compare the next generation ENVI™-SR with Solitaire™ (Medtronic).
"The initiation of this clinical trial in China is an important milestone for our new generation mechanical thrombectomy technology," said Jim Ma, CEO of NeuroVasc. "We are pleased with this progress as the NeuroVasc ENVI™-SR device has the potential to improve patient outcomes for the management of acute ischemic stroke."
Stroke is one of the leading causes of death in China. A stroke occurs when the blood supply to part of the brain is interrupted or reduced by a clot, 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 other complications.
"We are very pleased to begin this study to evaluate Envi-SR MT System which has a unique segmented design," said Dr. Zhaoshuo Li, Deputy Director of Interventional Department, HeNan Province People’s Hospital, who performed the procedure. "We are continuously working to improve treatment for our patients through both our tools and techniques. The Envi-SR was designed to address the gaps that we have found with traditional stent-retrievers and we are very excited to have the opportunity to investigate this new device."
The results of the study will support NMPA market approval for the ENVI™-SR device in China, further expanding our commercial footprint and providing a strong foundation for NeuroVasc’s future pipeline of game-changing neurovascular technologies.
The ENVI™-SR is a third generation clot retrieval device for use in patients experiencing acute ischemic stroke. The ENVI-SR was developed with the support of physicians from Canada, China, Japan, France, UK, and the US. The ENVI™-SR has received CE Mark and is currently under investigation in China with the US slated to begin later in 2021. The ENVI™-SR is available in a range of sizes to not only treat proximal occlusions but has also been designed to treat middle and distal vessel occlusions. The ENVI™-SR is not commercially available in China, and is pending FDA Clearance, not available for sale in the United States.
NeuroVasc Technologies, Inc. is a private company founded in 2015 and dedicated to advancing neurovascular innovation. Unlike other start-ups, NeuroVasc’s efforts are not just to develop a single product or single family of products, but to assemble a leading catalog of products—internally developed and acquired—to address unmet needs in the treatment of neurovascular disease. Its current core product is a next-generation mechanical thrombectomy system that is designed to improve device’s clot retrieval capabilities in tortuous anatomy.
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