Core Viewpoint - The article discusses the significant transformation in the drug-coated balloon (DCB) market, highlighting the shift in focus from product creation to the ability to provide long-term, stable delivery and verifiable system capabilities in real-world scenarios. It introduces Yixin Medical as a representative company that has developed a comprehensive product capability for disease management in heart failure, valve treatment, and coronary revascularization [1][3]. Group 1: Yixin Medical's Innovations - Yixin Medical holds two "global firsts" in its product offerings [2]. - The company’s independently developed Smartbird® paclitaxel drug-coated balloon received market approval in 2023 and has garnered positive clinical feedback, showcasing its systemic capabilities in research, validation, and registration [3][4]. - The ReDS™ Pro non-invasive lung water measurement device represents a shift in heart failure management from symptom control to precise monitoring, allowing for real-time and visual quantification of fluid overload [4][9]. Group 2: Product Details and Clinical Applications - The ReDS™ Pro device is the first non-invasive heart failure management device that meets the "5A principles," enabling real-time measurement of previously invisible lung water [5]. - The polymer valve system is the first TAVR product using polymer leaflets, marking a transition from metal to polymer in structural heart disease treatment [5]. - Over 50 global clinical research projects related to the ReDS™ technology have been initiated, contributing significant data and clinical experience from top institutions in China [7]. Group 3: Market Dynamics and Future Prospects - The DCB market has seen substantial growth, with annual usage increasing from 7,500 units in 2016 to 290,000 units in 2021, and projected to reach 1 million units by 2025 [20]. - The market size is expected to grow from 2.01 billion yuan in 2021 to 5.933 billion yuan by 2030, indicating a robust compound annual growth rate [20][23]. - The recent inclusion of DCBs in national volume-based procurement signifies a structural upgrade in the industry, shifting competition from price to value [25]. Group 4: Systematic Innovation and Future Directions - Yixin Medical is transitioning from single product innovation to systematic platform innovation, expanding into more complex areas such as valve replacement systems [26]. - The SIKELIA® transcatheter aortic valve replacement system utilizes polymer leaflets and is designed for a theoretical lifespan of 20-25 years, broadening its applicable patient population [26]. - The MitraFix® system is noted for being the only solution globally that allows for three different access routes, enhancing procedural safety and efficiency [28]. Group 5: Conclusion and Vision - Yixin Medical's innovations reflect a comprehensive technological landscape that addresses specific clinical challenges while expanding the boundaries of cardiovascular device innovation in China [29]. - The company aims to build an integrated "product + service" system to promote the accessibility of advanced cardiovascular technologies [30].