最新产品在中国首次植入还不到三个月，波士顿科学宣布其心脏瓣膜产品在全球范围退市

Core Viewpoint - Boston Scientific has announced the global withdrawal of its TAVR valve ACURATE series (ACURATE neo2™ and ACURATE Prime™) just three months after its commercial launch in China, indicating significant regulatory challenges and market dynamics [1][2]. Company Summary - The ACURATE series was considered a key player in Boston Scientific's strategy within the structural heart disease sector, competing with leading companies like Edwards Lifesciences and Medtronic [2]. - The ACURATE neo2 has been launched in over 60 countries, serving more than 80,000 patients globally [2]. - The decision to withdraw the product was influenced by discussions with regulatory bodies, which indicated that higher clinical and regulatory standards would be required for continued use in approved markets and for new market approvals [1]. Industry Summary - The TAVR market is characterized by high entry barriers and concentrated competition, with Edwards Lifesciences holding a 57.9% market share and Medtronic at 28.5%, together accounting for over 85% of the market [2]. - In China, the penetration rate for TAVR procedures is low, with only 25.83% of the 604 hospitals qualified to perform TAVR actually conducting the procedures, and about 73% of these surgeries occurring in the top 20 hospitals [2]. - Domestic brands, such as Qiming Medical and Xintong Medical, dominate the TAVR market in China, with a combined market share of approximately 80% in terms of implant volume [3].