最新！又1款创新器械获批上市！

Core Insights - The article highlights the upcoming global medical conferences and the approval of an innovative product by KOKAI (Nantong) Life Sciences Co., Ltd. for transcatheter mitral valve repair [1][14] - The global and Chinese market for mitral regurgitation (MR) is experiencing growth in both prevalence and surgical procedures, indicating a rising demand for innovative medical solutions [4][8][11] Product Overview - The product consists of a clamping device and delivery system, along with a catheter sheath assembly, designed for patients with high surgical risk and suitable anatomical structures for MR≥3+ [3] - It employs a percutaneous approach, making it less invasive compared to traditional surgical methods [3] Market Overview - The global prevalence of moderate to severe mitral regurgitation increased from 1.25% in 2017 to 1.28% in 2021, with an expected rise to 1.37% by 2027, translating to an increase in patient numbers from 93.5 million in 2017 to an estimated 114 million by 2027 [4][6] - The number of global transcatheter mitral valve repair procedures grew from 15,300 in 2017 to 27,700 in 2021, with projections to reach 104,300 by 2027, reflecting a compound annual growth rate (CAGR) of 24.7% from 2021 to 2027 [6][7] Chinese Market Insights - In China, the prevalence of moderate to severe mitral regurgitation among individuals over 35 years increased from 1.31% in 2017 to 1.37% in 2021, with an expected rise to 1.42% by 2027, indicating a growth in patient numbers from 10 million to 12.6 million [8] - The number of transcatheter mitral valve repair procedures in China is projected to increase from approximately 200 in 2021 to 20,000 by 2027, representing a remarkable CAGR of 117.3% [11][12] Company Profile - KOKAI (Nantong) Life Sciences Co., Ltd. was established in September 2018, focusing on the research, development, production, and sales of medical devices for structural heart diseases [13] - The company boasts a technical team primarily composed of returnees from the US and Germany, possessing extensive experience in cardiac medical technology, positioning it at the forefront of domestic innovation [13]