WILLIS® Intracranial Stent Graft System Received SFDA Approval

Recently, WILLIS® intracranial stent graft system (hereinafter referred to as WILLIS®) received the official certificate of regulatory approval from the People's Republic of China's (the "PRC") State Food and Drug Administration. WILLIS®, researched and developed independently by MicroPort NeuroTech (Shanghai) Co., Ltd. (hereinafter referred to as MicroPort NeuroTech) is first-of-its-kind product in China indicated for the treatment of intracranial aneurysms.
"WILLIS® has superior efficacy and safety features. Furthermore, it provides better treatment option for patients with intracranial aneurysm." said Mr. Zhiyong Xie, General Manager of MicroPort NeuroTech.
WILLIS® intracranial stent graft system is composed of the stent, delivery system, cobalt-based alloy stent and PTFE graft. Intracranial aneurysm is a cerebrovascular disorder in which weakness in the wall of a cerebral artery or vein causes a localized dilation or ballooning of the blood vessel. Its incidence rate is as high as 2% to 4%. Once the aneurysm ruptures, the permanent disability and mortality rate is 40% and 33% respectively. Compared with the traditional method of stent-assisted coil embolization treatment, the procedure of vascular reconstruction using WILLIS® effectively shunt the blood flow and keep it off of the aneurysm wall. The prospective, multi-center, controlled clinical study was held in three centers across the country and 87 patients were enrolled in the program. The 6-month follow-up clinical result from WILLIS® group demonstrated 95% closure rate which is far better than coil embolization treatment. In addition, the clinical application of Cerebral Aneurysms to its Related Vascular MRA Imaging, which based on clinical research of WILLIS® intracranial graft stent, obtained the First Class Award of Science and Technology Progress issued by the Ministry of Education.
"The introduction of WILLIS® into our portfolio of products available for sale in the PRC will further strengthen our position as the leading medical device player in the PRC. In addition, this technology demonstrates MicroPort's commitment to improving patient quality of life through continuous innovation in minimally invasive medicine and underlying corporate philosophy Where the Patient Always Comes First." Said Mr. Bo Pen, Chief Marketing Officer of MicroPort and Executive Director of MicroPort NeuroTech.
About MicroPort NeuroTech
MicroPort NeuroTech (Shanghai) Co., Ltd. is a wholly owned subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. and specializes in developing, manufacturing and marketing the medical devices in treating the central nervous system related vascular diseases. MicroPort Neurotech's main product APOLLO intracranial stent, which is first balloon-expandable intracranial stent in China designed to treat brain strokes, has 65% domestic market share. The new generation revascularization device Tubridge™ indicated for the treatment of large intracranial arterial aneurysm is undergoing the prospective, multi-center, randomized, controlled clinical trial. Various other cutting-edge products are in the research and development phases. Currently MicroPort NeuroTech has obtained 31 invention patents, 11 utility model patents. In addition, MicroPort NeuroTech is undertaking the "Twelfth Five-Year" National Science and Technology Support Program in the field of Risk Factors Prevention, Treatment, and Rehabilitation of Cerebral Vascular Disease.