The Chinese pivotal randomised controlled trial will assess the safety and efficacy of the mechanical thrombectomy system for endovascular treatment of acute ischemic stroke
NeuroVasc Technologies has recruited the first patient in its ENVI-SR Mechanical Thrombectomy System (ENVI-SR) clinical study in China.
The Chinese pivotal randomised controlled trial is designed to assess the safety and efficacy of the mechanical thrombectomy system for endovascular treatment of acute ischemic stroke.
NeuroVasc’s trial will compare the next-generation ENVI-SR with Medtronic’s Solitaire device.
ENVI-SR is a third-generation clot retrieval device that facilitates the removal of blood clots in patients with acute ischemic stroke due to large vessel occlusion.
Led by professor Li Tianxiao, the procedure was carried out by Dr. Zhaoshuo at the HeNan Province People’s Hospital in China.
The data from the trial will be used by the company to receive approval from China’s National Medical Products Administration (NMPA) for the ENVI-SR device.
NeuroVasc CEO Jim Ma said: “The initiation of this clinical trial in China is an important milestone for our new generation mechanical thrombectomy technology.
“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.”
NeuroVasc has developed ENVI-SR stent-retriever by taking the support of physicians from Canada, China, Japan, France, the UK, and the US
The company already secured CE mark approval for the ENVI-SR stent-retriever and is currently under evaluation in China. NeuroVasc aims to submit an application to the US FDA by the end of this year.
The ENVI-SR, which is available in various sizes, is also suitable to treat middle and distal vessel occlusions in addition to proximal occlusions.