Landmark Achievement: China's First Domestically Developed Intracardiac Echocardiography Catheter Receives NMPA Approval

Recently, the National Medical Products Administration (NMPA) of China approved the registration application for the innovative product "Single-Use Intracardiac Ultrasound Diagnostic Catheter" produced by Jiangsu TINGSN Technology Co., Ltd. The registration certificate number is "GuoXieZhuZhun 20233061761".

Source: Official website of the National Medical Products Administration of China

It is worth mentioning that,TINGSN Sonic Eyes 10, developed by TINGSN, is the first domestically produced and approved high-end intracardiac echocardiography diagnostic catheter in China.

Intracardiac Echocardiography (ICE) involves mounting a miniature transducer on the tip of a catheter, which is then inserted through the femoral vein into the heart chamber. The transducer emits sound waves, and the returning echoes are processed by a computer to generate ultrasound images. ICE provides high-resolution, real-time imaging of the internal anatomy of the heart chambers, other catheters, and devices within the heart, as well as real-time monitoring of hemodynamic status. Unlike traditional ultrasound techniques, ICE offers high imaging quality, strong real-time performance, and nearly 360-degree observability, allowing for better assessment of cardiac function and pathological conditions. Additionally, physicians can more accurately identify lesion locations, determine the optimal surgical plan, and improve the success rate and outcomes of the procedure.

ICE integrates multi-dimensional cutting-edge technologies such as material development, transducer development, catheter packaging, precision mechanical transmission, and imaging algorithms, with core technologies monopolized by only a few overseas giants. Since the approval of overseas intracardiac ultrasound products by the FDA in 1999, they have been widely used in clinical applications.

In order to break through foreign technological monopolies, TINGSN has invested nearly 300 million yuan in research and development funds since 2019. It has introduced dozens of returned overseas Ph.D.s and top domestic R&D talents, building a complete R&D and production team covering transducer R&D, chip design and processing, bonding process development, ultrasound imaging algorithm development, and ultrasound modeling and navigation algorithm development. From the probe, steerable catheter to the host system, a complete high-technology barrier closed-loop ecosystem has been established. Through large-scale investment in high-end hardware equipment and high-precision semi-automated production control,Core components are all self-developed and self-produced, achieving low-cost and high-performance products.The advantages to address the fierce market competition in China and strategic arrangements for going overseas in the future.

 China's First Self-Developed Intracardiac Ultrasound Products TINGSN Sonic Eyes 10 and TINGSN FINDERS 1

Principal Investigator (PI) of TINGSN’s ICE Registration Clinical Trial – Professor Kong Xiangqing (Director of Cardiology Department at the First Affiliated Hospital of Nanjing Medical University, Jiangsu Provincial People's Hospital; Director of the Ministry of Education's Engineering Center for Intelligent Diagnosis and Treatment Technology and Devices; Director of the National Standardized Cardiovascular and Metabolic Diseases Center), once stated, “The domestically produced ICE product by TINGSN has been well clinically validated in treating arrhythmias and occlusion procedures. Its control method and imaging performance are consistent with imported products, and in certain scenarios, it performs even better than imported products. It can effectively guide surgeons to complete procedures faster and reduce exposure to X-rays for both surgeons and patients during surgery. We look forward to the early market release of TINGSN’s ICE product.”

While successfully completing the approval process for 2D intracardiac ultrasound, as one of the world's third teams with the capability to develop a self-researched chip for 4D ICE, TINGSN is accelerating the R&D of its 4D ICE intracardiac ultrasound product.Compared with 2D ICE catheters, 4D ICE catheters can simultaneously provide high-quality two-dimensional and real-time three-dimensional images (4D images), including three-dimensional volume and 4D color Doppler imaging., which can provide more intuitive and clear guidance for interventional cardiac surgeries, such as complex mitral valve repair and replacement procedures and the treatment of tricuspid regurgitation (TriClip), etc. It has broad application prospects in the field of complex structural heart disease and arrhythmia surgeries.

At the same time, TINGSN's ultrasonic three-dimensional mapping system is also under synchronous development. Based on the principles of ultrasonic imaging and ultrasonic positioning, the system uses an ultrasonic positioning catheter to detect, locate, and confirm cardiac internal coordinate information, construct real-time three-dimensional images of the heart chamber, and acquire corresponding electrical signal information, providing "GPS" navigation services within the heart chamber for subsequent ablation treatment.

In the field of intracardiac electrophysiology surgical treatment, TINGSN has also developed an ultrasound ablation system. This system uses interventional ultrasound energy focusing to replace traditional radiofrequency ablation therapy. The electrode catheter, equipped with an ultrasonic transducer, is delivered through the femoral vein to a specified location within the heart chamber, where it releases ultrasonic energy to cause necrosis of the internal endocardial tissue at the lesion site, thereby blocking abnormal conduction pathways and origin points.

 TINGSN Ultrasonic Ablation System Concept Diagram

In recent years, in order to improve the localization level of medical devices in China, a series of policies and measures have been introduced, shifting from "encouraging domestically produced" to "prioritizing domestically produced." With the introduction of supportive policies and advancements in innovative technologies, the process of independent innovation in China's domestic medical device industry has accelerated, significantly increasing the localization rate of products.

Against this backdrop, TINGSN has established a production-research center in China that integrates industry, academia, research, and medicine. It has engaged in in-depth cooperation with leading domestic scientific research institutions, national medical centers, and well-known regional medical institutions. The company is committed to building a localized innovation ecosystem and creating an elite team specializing in the development of core technologies such as transducer R&D, chip design, material development, software system construction, imaging algorithms, and ultrasound modeling. TINGSN will continue to focus on enabling more patients with heart disease to receive more effective treatments, becoming a warm, ambitious, and internationally influential Chinese medical device brand.