On September 3, 2024, a series of events for the National Drug Safety Publicity Week were held in Beijing. The Medical Device Clinical Trial Management Symposium was hosted by the Department of Medical Device Registration of the National Medical Products Administration (NMPA), organized by the Beijing Municipal Drug Administration, and co-organized by Peking University's School of Medicine and Peking University Third Hospital. Lei Ping, a member of the NMPA Party Leadership Group and Deputy Administrator, attended the meeting and delivered a speech. Cao Wei, Director of the Beijing Municipal Drug Administration, also attended and gave a speech, while Li Dachuan, Deputy Director of the Medical Administration Department of the National Health Commission, and Lin Hang, Vice Mayor of Haidian District, participated in the event.
As a representative of domestic innovative medical device companies, AccuMedical was invited to attend the symposium and showcase its products.
The symposium, themed "Strengthening Clinical Trial Quality Management and Promoting Medical Device Innovation and Development," aimed to publicize the policies and regulations regarding medical device clinical trial management, create a communication platform for clinical trial institutions, sponsors, researchers, and regulatory authorities, and promote the high-quality development of the medical device industry.
Lei Ping, a member of the NMPA Party Leadership Group and Deputy Administrator, attended the symposium and delivered a speech. He emphasized that clinical trials are a critical method for evaluating the safety and effectiveness of medical devices. The NMPA will continue to improve the regulatory framework, strengthen the management of clinical trial institutions, and enhance the quality of clinical trials, working together with all stakeholders to foster a healthy clinical trial ecosystem.
Cao Wei, Administrator of the Beijing Municipal Drug Administration, stated that the Bureau would implement the NMPA's requirements and plans in depth, coordinating development and safety. On the one hand, they will steadily promote "dual filing" for clinical trials and continually strengthen "dual inspections" to reduce risks associated with clinical trial processes. On the other hand, they will collaborate with multiple departments to optimize the business environment, improve evaluation and approval efficiency, and boost the high-quality development of the medical device industry.
At the symposium, AccuMedical showcased its core product, the Lattice® Flow Diverter. Lei Ping, Deputy Administrator of the NMPA, Cao Wei, Administrator of the Beijing Municipal Drug Administration, as well as other drug administration leaders and experts, including Fu Wei, Director of Peking University Third Hospital, visited AccuMedical's booth and inquired about the product's R&D and clinical applications.
The Lattice® Flow Diverter is the first flow diverter to extend the indications to the treatment of medium and small vertebral artery aneurysms. By creatively integrating a mechanical balloon delivery system and MIROR surface modification technology, it represents a novel surgical approach for intracranial aneurysm treatment, which has rapidly developed and matured internationally over the past decade.
Compared to traditional intrasaccular coiling procedures, AccuMedical's Lattice® Flow Diverter streamlines the treatment process for aneurysms. Its unique mechanical balloon system enhances precision and ensures smooth stent deployment, effectively addressing challenges such as stent kinking and vascular injury commonly seen in traditional surgeries. Additionally, the MIROR surface modification technology further enhances surgical safety and patient outcomes.
Clinical data demonstrates that Lattice achieves a 91.4% aneurysm occlusion success rate and an in-stent restenosis rate of only 0.8% at 12-month post-surgery. By significantly reducing surgical complexity, it enhances the accessibility of intracranial aneurysm treatments. Today, Lattice is not only used in renowned top-tier hospitals in major cities but has also been widely adopted by county-level hospitals.
Thanks to its deep technical foundation and continuous innovation in the neurointervention field, AccuMedical was recognized as a "Specialized, Refined, Featured, and Innovative" small and medium-sized enterprise by Beijing in 2022 and awarded "National High-Tech Enterprise" status in 2023.
At the National Drug Safety Publicity Week opening ceremony, the NMPA stated that, in recent years, it has strictly implemented General Secretary Xi Jinping’s "Four Strictest" requirements, focusing on high-efficiency regulation to ensure high-level safety and promote high-quality development. China's pharmaceutical management regulatory system has been continuously improved, drug safety remains generally stable, and the pace of market approval for innovative drugs and medical devices has accelerated. The NMPA has also made solid progress in strengthening drug regulatory capabilities, effectively protecting and promoting public health.
As an innovative company in the neurointervention field, AccuMedical aims to actively contribute to national medical innovation, ensuring high-level safety and the high-quality development of the industry, continuing to drive "genuine innovation and practical application" in the field of Chinese-made neurointerventional medical devices, and safeguarding public health and people’s lives with better products.