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].
突破金属限制！又一可降解封堵器进入创新通道