Another Domestic MedTech Giant Enters the Arena: ICE Industry Reaches Critical Juncture for Localization

Medtech Intelligence Network News: In recent years, with the rapid development of interventional diagnosis and treatment technologies for structural heart disease and arrhythmia, the requirements for intraoperative imaging have been increasing.The application scope of ICE technology is becoming wider, and ICE catheters are gradually becomingInterventional Cardiologist's"Golden Eye"。

On March 26, 2025, the NMPA announced the review results of the special review application for innovative medical devices. Fourteen products have entered the innovation channel, including Shanghai MicroPort EP MedTech Co., Ltd. (referred to as "MicroPort EP"）Application for"Single-Use Intracardiac Echocardiography Imaging Catheter。This means that the product's approval process is accelerating.

Made in ChinaICE Track and Players

The number of cardiac interventional surgeries in China is increasing year by year, but the popularity of intracardiac ultrasound in China is not high. Taking atrial fibrillation radiofrequency ablation as an example, the application rate of intracardiac ultrasound in this type of surgery in China...Lower. According to relevant data: in the electrophysiology procedures in the United StatesThe penetration rate of ICE has exceeded 90%. In contrast, the penetration rate of ICE in China is very low, indicating a potential for market explosion.

ICE products integrate multi-dimensional cutting-edge technologies such as material development, transducer design, catheter packaging, precision mechanical transmission, and imaging algorithms. These products feature high technical barriers and a highly concentrated market.According to reports,Intracardiac Ultrasound Market in ChinaFor a long timeCompletely monopolized by multinational device companies.In 2023,Johnson & Johnson occupies86.57% of the market share, Abbott ranks second with 11.94% of the market share.

With the rapid development of domestic substitution, there are currently mainly4 Chinese-made (includingTINGSN、HeartSpan Tech、Ice Crystal Intelligence、Saihe Medical）ICE Product Approved. Review of 2023~2024In ..., TINGSN, a leading enterprise in China's intracardiac ultrasound sector, announced that its..."Single-Use Intracardiac Ultrasound Catheter" Officially received the approval from the National Medical Products Administration (NMPA) approved for marketing, becoming the first domestically produced ICE system in China (catheter + main unit) to enter the innovation green channel and gain approval., Initiate domestically producedThe Era of ICE Catheters.

TINGSNStill inICCD2025 Electrophysiology Industry Development Trends Conference revealed to Intelligent Medical Device Network:Currently, the companyCatheter annual production capacity reachesOver 60,000 units+, high-efficiency production capacity meeting international quality standards.In the next few years, TINGSNWill vigorouslyInvestmentResearch and development, process improvement, derivative product development, and the construction of a supporting talent team for 4D intracardiac ultrasound.

MicroPort EP DebutsICE Stage

It is reported that MicroPort EP, which has entered the innovation channel this time,ICE catheter, with 3D ultrasound positioning function, compatible with ultrasound imaging devices and Columbus^®The 3D cardiac electrophysiological mapping system, when used in cardiac interventional procedures, can simultaneously obtain high-definition intracardiac structures and corresponding three-dimensional positions of other instrument images.

According to the news from Smart Medical Device Network, MicroPort EPRecentlyNewly Obtained a Utility Model Patent Authorization, Patent Name:"Intracardiac Ultrasound Catheter and Intracardiac Ultrasound Imaging Equipment"Involves an intracardiac ultrasound catheter and an intracardiac ultrasound imaging device. The catheter body has a bendable catheter segment and a non-bendable catheter segment in its axial direction. A handle device is located in the proximal region of the catheter body, with a circuit control unit installed inside the handle device. An ultrasound transducer is positioned in the distal region of the catheter body. A flexible circuit connection component runs axially through the inner cavity of the catheter body. The ultrasound transducer is connected to the circuit control unit within the handle device via the flexible circuit connection component. The flexible circuit connection component includes at least two flexible connection elements, with circuit connection nodes formed between adjacent flexible connection elements. These circuit connection nodes are located either in the non-bendable segment of the catheter body or within the inner cavity of the handle device. Neither the ultrasound transducer nor the circuit control unit forms weak points with the flexible connection elements. Positioning the circuit connection nodes in the non-bendable segment of the catheter body or within the inner cavity of the handle device prevents damage to these weak points.

Professor Chu Huimin, who is responsible for the pre-market clinical trials of this product, believes:"The intracardiac ultrasound catheter developed by MicroPort EP boasts excellent imaging quality and smooth maneuverability, combined with Columbus."^®The spatial visualization achieved by the 3D cardiac electrophysiological mapping system effectively improves surgical efficiency and reduces"X-ray Usage".

Industry Outlook

As early asIn 2014, Siemens Healthineers' intracardiac echocardiography (ICE) catheter was approved for registration in China. With the continuous development of technology, imported brands have improved from the initial 2D imaging to 4D imaging, and currently, all use 4D ICE catheters. The development of ICE in China started relatively late; domestically produced brands still mainly focus on 2D, and 4D ICE is still in the clinical stage.

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. This allows for more intuitive and clearer guidance during interventional cardiac surgeries and has broad application prospects in the performance of complex structural heart disease and arrhythmia procedures.

From the perspective of existing product registrations, Johnson & Johnson, Abbott, and Boston Scientific all lackIEC-Compatible Ultrasound Hosts: For instance, the intracardiac ultrasound catheter represented by Johnson & Johnson's Biosense Webster is compatible with Siemens ultrasound hosts, while Irvine Biomedical, represented by Abbott, is compatible with Philips and Mindray ultrasound hosts. This situation somewhat restricts companies from independently selecting markets, which is not conducive to the expansion of market channels. Additionally, it complicates maintenance and after-sales services, making product promotion more challenging.。

On the contrary,The intracardiac ultrasound catheter produced by Jiangsu TINGSN Technology Co., Ltd. is compatible with its self-developed and produced ultrasound host. In addition to TINGSN, Saihe Medical and Huafeng Medical are also...The intracardiac ultrasound imaging system featuring "consumables + equipment" grants companies greater autonomy in market expansion, and the integrated after-sales service for consumables and equipment is more favored by medical institutions.It can be foreseenThe market share of domestic brands is expected to achieve rapid growth in the future.。

In addition,Structural opportunities brought by centralized procurement,PFA Technology Innovation and Growth in the Grassroots Market,AlsoWill provide opportunities for Chinese manufacturers to overtake on the curve.On August 26, 2022, the Fujian Medical Insurance Bureau released the "Inter-provincial Alliance Centralized Volume-based Procurement Plan for Cardiac Interventional Electrophysiology Medical Consumables (Draft for Comments)." The 10F 2D ICE catheter was officially considered for volume-based procurement, marking the beginning of centralized volume-based procurement for intracardiac ultrasound catheters.

From the 2023 annual centralized procurement situation, brands have experienced price reductions to varying degrees. Abbott's average unit price decreased by 48.6% compared to the listed price, while Johnson & Johnson's average unit price dropped by 36.3%. Imported brands saw significant price reductions at the terminal end, leading to a substantial compression of profit margins for imported products, reducing their attractiveness to distributors and significantly weakening the channel advantages of imported brands. Domestic brands, with relatively lower costs, have won considerable market share through "price wars" in previous consumables procurement. To a certain extent, consumables procurement has accelerated the process of domestic substitution.。

Authoritative data shows,GlobalICE is mainly applied in electrophysiology and left atrial appendage closure, accounting for nearly 45%, with atrial fibrillation making up the vast majority. The penetration rate of ICE in electrophysiology in China is 9% (only one-tenth of that in the United States).It is understood that,In 2024, the number of electrophysiology procedures in China exceeded 40.Ten Thousand Units, year-on-year growth20%。With the rapid promotion of interventional procedures for structural heart diseases such as congenital heart disease, valvular heart disease, cardiomyopathy, and large vessel diseases,The penetration rate of ICE catheters in interventional treatments for structural heart disease will increase rapidly.