NeuroVasc’s Envi-SR Mechanical Thrombectomy System Studied in China

September 23, 2021—NeuroVasc Technologies, Inc. announced that the first patient has been treated in ENVI-SR, the Chinese pivotal trial for the company’s Envi-SR mechanical thrombectomy (MT) system. The results of the study will support regulatory approval by China’s NMPA in the Chinese market for the Envi-SR device. The Envi-SR system is a third-generation stent retriever for the removal of blood clots in patients with acute ischemic stroke caused by large vessel occlusion.

According to the company, the study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of Envi-SR system for endovascular treatment of acute ischemic stroke. The study will compare the next-generation Envi-SR with the Solitaire device (Medtronic).

The first procedure was performed by Zhaoshuo Li, MD, who is Deputy Director of Interventional Department and associate professor of the Stroke Center directed by Professor Li Tianxiao, MD, at the Henan Province People’s Hospital in Zhengzhou, China.

“We are very pleased to begin this study to evaluate Envi-SR MT system which has a unique segmented design,” commented Dr. Li in the company’s announcement. “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.”

NeuroVasc stated that in Europe, the Envi-SR device received CE Mark approval and is available in a range of sizes to treat proximal occlusions. It is also designed to treat middle and distal vessel occlusions.

The device is currently under investigation in China and is not commercially available. In the United States, FDA clearance is pending, and it is not available for sale, advised the company.