China's First Domestic Intracranial Thrombectomy Aspiration Catheter System by Horizon Medical Receives NMPA Approval, Reducing Disability Rates in Ischemic Stroke
In May 2021, Hemu (China) Bioengineering Co., Ltd. (hereinafter referred to as “Hemu China”) announced Afentta, the first domestically produced intracranial thrombus aspiration catheter system in ChinaTMApproved for market launch by the National Medical Products Administration. This innovative product, featuring independent intellectual property rights and evidence-based medical support, provides an efficient, rapid, and safe interventional aspiration thrombectomy solution for patients with acute ischemic stroke in China, further reducing disability rates and alleviating the disease burden.
Figure: Afentta Intracranial Thrombus Aspiration Catheter SystemTM
Stroke is the “leading killer” of public health, ranking first among all causes of death and disability in Chinese adults. It poses five major hazards: high incidence, high disability rate, high mortality, high recurrence rate, and substantial economic burden. Acute ischemic stroke accounts for approximately 70% of all stroke cases in China, leading to death within 90 days in about 10% of patients and causing disability in more than one-third of survivors. The Healthy China Action (2019–2030) proposes reducing cardiovascular and cerebrovascular mortality by nearly 20%. This year, the Bureau of Medical Administration and Hospital Management of the National Health Commission included increasing the reperfusion therapy rate for acute cerebral infarction as a key objective in the “2021 National Goals for Improving Medical Quality and Safety.”
Interventional thrombectomy for acute ischemic stroke is recommended by global guidelines, as it effectively recanalizes large cerebral vessels, promptly restores blood supply, and improves prognosis. Professor Miao Zhongrong, Director of the Neurointerventional Center at Beijing Tiantan Hospital, Capital Medical University, stated: "Previously, aspiration catheters relied entirely on imports. This domestically produced intracranial thrombus aspiration catheter system features an innovative design that shortens procedural time, achieves high rates of vascular recanalization, reduces patient disability, and lowers the incidence of arterial dissection. It provides a more efficient, rapid, and safe interventional thrombectomy solution for the treatment of acute ischemic stroke."
Multiple clinical study data show that this intracranial thrombus aspiration catheter system design enables closer proximity to the thrombus, achieving a recanalization rate of 93.2%, higher than the 74.2% observed with other catheters, with an average thrombectomy procedure time of 19–24 minutes. Patients demonstrated better functional independence scores at 90 days and a significantly reduced disability rate. The aspiration catheter system recently approved for Hemu China features upgraded and improved international technical standards, better suited to Chinese patients’ vascular anatomy, while offering superior flexibility and pushability.
Figure: Production process at Hemu’s China factory
The Intracranial Thrombus Aspiration Catheter System is a core technology R&D project of Hemu China. Prior to the approval of this product, only imported equivalents were available in the Chinese market. Dr. Wang Jicheng, Founder and Chief Technology Officer of Hemu China, stated that Hemu China is committed to leveraging the world’s most intelligent resources to serve China and developing innovative products in the field of vascular intervention. With a professional and experienced management team, diversified R&D capabilities, and international academic resources, the company provides globally leading and reliable innovative technological products. Hemu China has established technical collaborations with Imperative Care, a leading industry company in Silicon Valley, USA, and the Department of Chemical Engineering at Tsinghua University, while advancing clinical trials in partnership with Beijing Tiantan Hospital, Capital Medical University. By achieving China’s first independent intellectual property rights in this area, Hemu China has resolved the critical bottleneck issue concerning key medical devices for intracranial aspiration catheters. In the future, Hemu China will continue to dedicate itself to promoting the rapid development of interventional therapy in China. In addition to product innovation and R&D, Hemu China will actively participate in the construction of stroke centers across various regions and the training of primary-care physicians, ultimately benefiting a broad population of Chinese patients and supporting the implementation and achievement of the goals outlined in the “Healthy China 2030” strategy.
Hemu (China) Bioengineering Co., Ltd. officially commenced operations in 2017, with its R&D headquarters located in Weihai, China, and operational centers established in Beijing and Shanghai. As a rapidly growing innovative platform enterprise in the field of neurointerventional medical devices, Hemu provides comprehensive neurointerventional solutions for cerebrovascular diseases, including ischemic stroke, hemorrhagic stroke, and intracranial arterial stenosis. Throughout the entire product lifecycle, the company adheres to stringent quality and safety standards to ensure the highest level of product reliability. Leveraging diversified R&D capabilities and international academic resources, Hemu continuously develops globally leading innovative technologies and products, while strategically deepening its presence in the neurointerventional sector and related fields.