Core Viewpoint - The article highlights the advancements in biodegradable septal occluders in China, particularly focusing on the recent approval of innovative products by companies like Shanghai Jinkui Medical and Lepu Medical, marking significant progress in the treatment of atrial septal defects (ASD) [2][3]. R&D Background - Atrial septal defect (ASD) is a common congenital heart defect, accounting for approximately 10% of all congenital heart diseases and 20%-30% of adult congenital heart diseases [3]. - The standard treatment for ASD involves the implantation of septal occluders, which traditionally are made of metal and can lead to complications such as nickel ion release and thrombosis [4]. Company Product Introduction - Shanghai Jinkui Medical has developed a biodegradable septal occluder, which is expected to enhance the domestic high-end innovation landscape in the field of ASD treatment [2]. - The Pansy biodegradable PFO occluder features improved shape recovery, biocompatibility, and a reasonable absorption cycle, having completed prospective multi-center clinical trials [6][11]. Product Features - The Pansy occluder is designed to provide sufficient support for the repair of the defect while being gradually absorbed by the body, with degradation products being harmless [7]. - The Mallow® single-rivet septal occluder is a domestically innovative product that is suitable for various types of ASD interventions [10]. Market Trends - The number of ASD occlusion procedures in China has shown a compound annual growth rate (CAGR) of 32.17%, increasing from 33,200 cases in 2021 to 58,000 cases in 2023 [13]. - The market for septal occluders in China is projected to grow from 155 million RMB in 2017 to 382 million RMB by 2027, with a CAGR of 6.4% from 2021 to 2027 [13]. Company Overview - Jinkui Medical, established in 2003, specializes in the R&D, production, and sales of cardiovascular interventional high-value consumables, with several innovative products already approved for market [28].

Core Viewpoint - The article highlights the advancements in the medical technology sector, particularly focusing on innovative medical devices that have received special review status from the NMPA, indicating a growing trend in the industry towards innovation and regulatory support [1]. Company Summaries - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is a leading global medical device supplier, established in 1991, with a revenue of 36.73 billion yuan in 2024, reflecting a 5.1% year-on-year growth, and a net profit of 11.67 billion yuan, up 0.7% [5]. - Wuxi Reiming Vision Technology Co., Ltd. specializes in the research and production of artificial lenses, having developed advanced hydrophobic acrylic materials and received CE certification for its products, indicating its strong R&D capabilities [6]. - Shenzhen Gamma Knife Technology Co., Ltd. has been focused on high-end medical equipment, particularly in radiation therapy, since its establishment in 1993, showcasing its commitment to innovation in the medical technology field [7]. - Suzhou Puno Medical Technology Co., Ltd. is a national high-tech enterprise founded in 2020, dedicated to the development of products related to tumor brachytherapy, emphasizing its strong R&D capabilities and innovative approach [10]. - Hangzhou Aijinglun Technology Co., Ltd. is an innovative ophthalmic medical device company established in 2015, known for its unique suspension-type intraocular lens, which fills a gap in the market for high-degree correction lenses [13]. - Beijing Shanning Kezhi Medical Device Co., Ltd. focuses on biodegradable zinc alloy technology, with products entering clinical trials, showcasing its innovative approach in the biomedical field [15]. - Medtronic, a global leader in medical technology founded in 1949, operates in over 70 disease areas, providing lifelong treatment solutions for chronic disease patients [18]. - Shanghai Yangshan Biotechnology Co., Ltd. was established in 2023, collaborating with top hospitals and dental clinics, indicating its strong market positioning in the dental sector [19]. - Xiamen Shide Medical Equipment Co., Ltd. emphasizes innovation in surgical instruments, having obtained numerous patents and certifications, and is recognized for its diverse product line [20][21]. - Guangzhou Xinhanglu Medical Technology Co., Ltd. focuses on innovative cardiac electrophysiology products, with a unique four-dimensional mapping system that enhances treatment precision [22]. - Shanghai Jinkui Medical Device Co., Ltd. specializes in cardiovascular interventional materials, having developed several pioneering products and maintaining strong R&D partnerships [23]. - Guokexin Medical Technology Co., Ltd. is engaged in the development of advanced medical equipment for boron neutron capture therapy, marking a significant advancement in cancer treatment technology [24]. - Shanghai Ruining Biotechnology Co., Ltd. focuses on high-end biomedical materials, with a strong emphasis on innovation and collaboration with leading cancer treatment centers [25]. - Suzhou Sainasi Medical Technology Co., Ltd. is dedicated to cardiac electrophysiology, providing innovative solutions and a comprehensive product line for the medical field [26].