According to reports,The patient in this surgery is a 65-year-old woman who was admitted for treatment due to "atrial fibrillation combined with gingival and skin bleeding" and was assessed to have a high risk of stroke and bleeding.After full communication with the patient and their family, the surgical team decided to use the SONOSEMI ICE system to perform a left atrial appendage closure procedure.

Guided by the ICE system and relying on extensive experience, the surgical team safely and precisely completed the operation in less than an hour.The surgery was successfully completed, resolving the dual challenges of thrombosis prevention and bleeding for the patient.

Intracardiac Echocardiography (ICE) is a medical device that integrates a miniature transducer at the tip of a catheter. The catheter is inserted through the femoral vein into the cardiac chambers, where the transducer emits sound waves. The returning echoes are processed by a computer to generate ultrasound images, providing high-resolution, real-time ultrasound visualization of the internal anatomy of the heart chambers and other interventional devices within the heart.ICE can monitor hemodynamic status in real time and observe cardiac structure and function from within the heart chambers.

However, the technical barriers of ICE are extremely high, requiringMaterial Development, Transducer Development, Catheter Packaging, Precision Mechanical Transmission, Imaging AlgorithmsSupported by multi-dimensional cutting-edge technologies. Before 2023, these core manufacturing technologies were completely reliant onMonopoly by foreign enterprises.

In 2023, Professor He Ben, as the Principal Investigator (PI), led the completion of China's first domestically produced ICE system prospective, multicenter registration clinical trial project (DISTINCT Clinical Trial).The research results show that the overall performance of SONOSEMI's ICE system, including catheter maneuverability and image quality, not only reaches the level of similar imported products but even surpasses them in some indicators, breaking through the technical bottleneck in this field in China.

With this breakthrough, SONOSEMI's ICE system has entered the NMPA Innovative Medical Device Special Review Process and has becomeThe first domestically produced ICE system in China to enter the innovative green channel,Filled the gap in this field that has long relied on imported products.

SONOSEMI Intracardiac Ultrasound Imaging System

It is understood that,SONOSEMI's intracardiac echocardiography imaging system consists of the DynaSight® single-use intracardiac echocardiography catheter (NMPA approval No.: 20243061274) and the UDG3900 series portable ultrasound diagnostic device (NMPA approval No.: 20243061271).The system continuously emits ultrasonic signals and receives echoes through the miniature phased-array probe at the tip of its ICE catheter, providing real-time, high-quality images of the intracardiac anatomical structures. It is an essential auxiliary tool in cardiac interventional therapy.

As a domestically innovated and self-developed ICE system, the superior performance of SONOSEMI's products excelled in China's first clinical trial project for a domestically produced intracardiac echocardiography system (DISTINCT trial), earning recognition from clinical experts.Highly Evaluate, all indicateThe overall performance, including catheter maneuverability and image quality, has reached and partially exceeded the level of imported similar products.

More importantly, the system has a greater detection depth through innovation, which is not only suitable for all routine cardiac interventional surgeries but also optimizes the operation of left atrial appendage occlusion under intracardiac echocardiography guidance, improving surgical efficiency and reducing complications.

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China's innovative medical devices are speeding up on a fast track, from catching up to running neck and neck, and then to surpassing. New products are being launched at all levels. The successful application of the domestically produced ICE system independently developed by SONOSEMI undoubtedly sets a new benchmark for the independent innovation of high-end medical devices in China. It also represents an important step for domestically produced medical devices moving from "addressing weaknesses" to "creating leadership." In the future, with the emergence of more innovative domestic medical devices, we will witness more and more "Chinese wisdom." Medical Device Frontline will continue to follow up.