HeMo China's Afentta™ Receives NMPA Approval as China's First Domestic Intracranial Thrombectomy Aspiration Catheter System, Reducing Disability in Ischemic Stroke Patients

BEIJING, SHANGHAI and WEIHAI, May 24, 2021 /PRNewswire/ -- In May 2021, HEMO (hereinafter referred to as "HEMO China") announced that Afentta, China's first intracranial thrombus aspiration catheter system produced in China,^TMApproved for marketing by the National Medical Products Administration (NMPA). This innovative product, backed by independent intellectual property rights and evidence-based clinical data, 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.

Afentta Intracranial Thrombus Aspiration Catheter System

Stroke is the "number one killer" of public health, ranking first among all causes of death and disability in Chinese adults. It presents five major hazards: high incidence, high disability rate, high mortality rate, high recurrence rate, and high economic burden.^[1]. Among them, acute ischemic stroke accounts for approximately 70% of stroke cases in China.^[2], can lead to death within 90 days in approximately 10% of patients, and disability in over one-third of patients^[3]. The Healthy China Initiative (2019-2030) proposes to reduce the mortality rate of cardiovascular and cerebrovascular diseases by nearly 20%.^[4]。This year, the "2021 National Medical Quality and Safety Improvement Goals" issued by the Bureau of Medical Administration of the National Health Commission also designates improving the reperfusion therapy rate for acute cerebral infarction as a key work objective.^[5]。

Endovascular thrombectomy for acute ischemic stroke can effectively recanalize large cerebral vessels, promptly restore blood supply, and improve prognosis, and is recommended by global guidelines. Professor Miao Zhongrong, Director of the Department of Neurointervention at Beijing Tiantan Hospital, Capital Medical University, stated: Previously, aspiration catheters relied solely on imports. This domestically manufactured intracranial thrombus aspiration catheter system features an innovative design that shortens procedural time, achieves a higher vessel recanalization rate, reduces patient disability rates, and decreases the incidence of arterial dissection. It provides a more efficient, rapid, and safe endovascular thrombectomy treatment regimen for the management of acute ischemic stroke.

Data from multiple clinical studies indicate that this designed intracranial thrombus aspiration catheter system enables closer proximity to the thrombus, achieving a recanalization rate of 93.2%, which is higher than the 74.2% observed with other catheters.^[6], the average thrombectomy procedure time was 19-24 minutes^[7]; better functional independence scores at 90 days, with a significantly reduced patient disability rate. The aspiration catheter system recently approved by HEMO China has been upgraded and optimized in line with international technical standards, is better suited to the vascular anatomy of Chinese patients, and offers superior flexibility and pushability.

HEMO China Factory Production Process

The Intracranial Thrombus Aspiration Catheter System is a core technology R&D project of HEMO. Prior to the approval of this product, only imported equivalents were available in China. Dr. Wang Jicheng, Founder and Chief Technology Officer of HEMO, stated: "HEMO is committed to integrating the world's most advanced intellectual and technological resources to serve China, and to developing innovative products in the vascular interventional field. Leveraging a professional and experienced management team, diversified R&D capabilities, and international academic resources, we provide globally leading and reliable innovative technological products." HEMO has established technological collaborations with Imperative Care, a leading industry player in Silicon Valley, and the Department of Chemical Engineering at Tsinghua University. Additionally, it has partnered with Beijing Tiantan Hospital, Capital Medical University, to advance clinical trials. Through independently owned intellectual property and first-of-its-kind innovations in China, HEMO has successfully resolved the critical bottleneck in key medical devices for intracranial aspiration catheters. Looking ahead, HEMO will remain dedicated to accelerating the development of interventional therapy in China. Beyond product innovation and R&D, HEMO will actively participate in the construction of regional stroke centers and the training of primary-care physicians, ultimately benefiting a broader patient population in China and contributing to the implementation and realization of the "Healthy China 2030" strategy.

[1] Summary of the "China Stroke Prevention and Treatment Report 2019", Chinese Journal of Cerebrovascular Diseases, May 18, 2020, Vol. 17, No. 5
[2] Wang WZ，Jiang B，Sun HX，et al ．Prevalence, incidence, and mortality of stroke in China: results from a nationwide population -based survey of 4 8 0 6 8 7 adults［J．Circulation，2 0 1 7, 1 3 5 ( 8 ): 7 5 9 -7 7 1．
[3] Hao Z, Liu M, Li W, et al. Methodology of the Chengdu Stroke Registry and baseline characteristics and functional outcomes of 3123 patients[J]. Chinese Journal of Neurology, 2011, 44(12): 826-831.
[4] Healthy China Action (2019-2030)_Departmental Affairs_Chinese Government Website (www.gov.cn)  
[5] Notice of the General Office of the National Health Commission on Printing and Distributing the 2021 National Goals for Medical Quality and Safety Improvement (nhc.gov.cn)
[6] Vargas J, et al. J NeuroIntervent Surg 2020; 0:1–5. doi:10.1136/neurintsurg-2020-016695
[7] Ali Alawieh, et al. NEUROSURGERY,2018