Core Viewpoint - The article highlights the advancements in transcatheter aortic valve replacement (TAVR) technology, particularly focusing on the innovative polymer valve developed by Yixin Medical, which has entered the innovation channel for medical devices in China [1][6][19]. Industry Overview - Aortic valve disease is a common cardiovascular issue, with a significant increase in incidence among the elderly, particularly those over 65 years old [2][4]. - By 2025, it is estimated that there will be approximately 9.3 million patients with aortic stenosis or regurgitation in China, posing a serious public health challenge [4]. - The demand for heart valve replacement surgeries is expected to grow rapidly due to the aging population and the increasing prevalence of heart valve diseases [12]. Product Introduction - Yixin Medical's SIKELIA is the world's first polymer valve TAVR system, which was successfully implanted in a clinical trial in July 2022 [6][8]. - The SIKELIA valve features a unique polymer material that offers advantages such as zero calcification, low coagulation, and high biocompatibility [8][9]. Product Advantages - SIKELIA has an expected lifespan of 20-25 years, significantly longer than traditional biological valves, which last about 10 years [9]. - The design of the valve reduces the risk of perioperative complications, such as conduction block, enhancing the safety of the implantation process [9]. - The valve is fully recoverable during implantation, providing flexibility in case of unexpected events during surgery [9][10]. - The material cost of SIKELIA is only 1/5 to 1/10 of biological valves, allowing for more affordable options for patients [10]. Clinical Trials - A prospective, single-arm, multi-center study involving 12 patients with aortic stenosis has been conducted, with follow-up extending up to 27 months [11]. Market Landscape - The prevalence of heart failure among adults aged 35 and older is 1.3%, with projections indicating that China will have 16.14 million heart failure patients by 2030 [12]. - The global heart valve market is currently dominated by mechanical valves (70% usage), while biological valves have a negligible market share [12]. Competitive Landscape - Yixin Medical is a leading player in the polymer valve market, having completed the first clinical trial of its polymer TAVR system [16]. - Other companies, both domestic and international, are also developing polymer valves, but Yixin Medical holds a competitive edge with its innovative technology [15][19].