Shenzhen SinoHeart Medical Completes World's First Clinical Applications of China-Developed Intracardiac Echocardiography (ICE) System

Recently, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, successfully completed a case of ICE-guided atrial fibrillation pulse ablation using the intracardiac echocardiography imaging system (ICE system) independently developed by SONOSEMI.

These are the world's first batch of clinical application surgeries for SONOSEMI's ICE system since its approval for marketing in July 2024. The same batch of clinical applications also includes cardiac interventional treatment surgeries completed at the General Hospital of the Northern Theater Command of the Chinese People's Liberation Army, and left atrial appendage closure procedures performed at Shanghai Chest Hospital.

Intracardiac Echocardiography (ICE) is an innovative echocardiographic diagnostic technique that places the ultrasound probe inside the heart chambers to emit and receive ultrasound signals, enabling real-time imaging of cardiac anatomical structures, cardiac hemodynamics, and cardiac function.

Based on different technical principles, intracardiac ultrasound catheters are divided into two types: mechanical rotating ultrasound catheters and phased array ultrasound catheters. Currently, phased array ultrasound catheters are mainly used in clinical practice.

Initially, intracardiac echocardiography (ICE) was only used for atrial septal defect and patent foramen ovale closure procedures. With the rapid development of interventional diagnosis and treatment technologies for structural heart disease and arrhythmias, the requirements for intraoperative imaging have increased. ICE does not require general anesthesia or the assistance of an ultrasound doctor, making it more convenient to use. Its imaging quality is comparable to transesophageal echocardiography. As a result, the application scope of ICE technology has expanded, and ICE catheters are gradually becoming the "golden eye" for interventional cardiologists.

In October 2022, the world's first expert consensus on intracardiac ultrasound, "Chinese Expert Consensus on Intracardiac Echocardiography," was published in the internationally renowned journal *Frontiers in Cardiovascular Medicine*. The consensus states that intracardiac ultrasound can be used to guide and monitor catheter ablation for arrhythmias, interventional procedures for congenital heart disease, interventional treatments for valvular heart disease, and other cardiac interventional procedures.

SONOSEMI's ICE system was approved for marketing by the NMPA in July 2024, marking the first domestically produced ICE system (catheter + host) in China to be approved after entering the innovative green channel.

SONOSEMI's Intracardiac Ultrasound Imaging System consists of the DynaSight single-use intracardiac ultrasound imaging catheter and the UDG3900 series portable ultrasound diagnostic device. The system utilizes the inverse piezoelectric effect to convert the pulsed electrical signals output by the portable ultrasound diagnostic device into ultrasound waves, which are emitted into the intracardiac tissue, and receives the echo signals transmitted back to the portable ultrasound diagnostic device. These signals are then converted into intraoperative image signals and displayed on the monitor.

Used together, the two products are for ultrasound imaging of adult heart, major cardiac vessels, and intracardiac anatomical structures.

Globally, well-known multinational corporations such as Johnson & Johnson, Abbott, Siemens, Philips, GE Healthcare, and Boston Scientific have all entered the intracardiac echocardiography (ICE) market.

As early as 2014, Siemens Healthineers' intracardiac echocardiography (ICE) catheter was approved for registration in China. With the continuous development of technology, companies such as Siemens, Johnson & Johnson, and Philips have launched or developed 3D and 4D intracardiac echocardiography products. The development of ICE in China started relatively late, and domestic brands still mainly focus on 2D, with 4D ICE still in the clinical research stage.

However, 4D intracardiac echocardiography and 2D intracardiac echocardiography are not in a substitutive relationship but rather a coexistent one: 4D intracardiac echocardiography has a smaller penetration depth and is more suitable for complex surgeries that do not require a high penetration depth; 2D intracardiac echocardiography is more appropriate for simpler surgeries that require a greater penetration depth but have lower resolution demands.

In China, innovative companies such as IceCrystal, SONOSEMI, TingSheng Technology, and HeartSpace Technology have started actively developing intracardiac ultrasound and have made breakthrough progress.

In May, Tingsn Medical announced that its independently developed and produced TINGSN Sonic Eyes 10 disposable intracardiac echocardiography diagnostic catheter has been commercially used and clinically trialed in dozens of well-known hospitals across China. The applications cover radiofrequency ablation, cryoablation, left atrial appendage closure, PFO, TAVR, and more.

TingSheng Medical's catheter was approved for marketing by the NMPA on November 28, 2023, marking China's first approved ICE diagnostic catheter.In July, TingSheng Medical completed a B+ round of financing exceeding 100 million yuan. Its product portfolio includes 2D ICE imaging systems, 4D ICE imaging systems, ultrasound 3D mapping systems, and ultrasound energy treatment systems.

CardioVation Tech continues to push the limits of craftsmanship, creating the world's thinnest ICE catheter size.In July, CardioViz announced that its self-developed global thinnest 2D ICE catheter had successfully completed a multi-center, randomized controlled, non-inferiority registration clinical trial and officially entered the registration review stage. The catheter is only 7.5F (with a cross-sectional area approximately 56% of a 10F catheter) while maintaining equivalent image quality, featuring handle self-locking and one-handed flexible operation.

Small-diameter catheters can further reduce the risk of potential puncture injuries and vascular complications, potentially expanding their use to include pediatric patients and those with small hearts. Additionally, these catheters can be used with existing 8.5F transseptal sheaths, allowing for easier access to the left atrium to guide procedures such as left atrial appendage closure.

Ice Crystal Intelligence is one of the few manufacturers in China that offers a full range of 2D, HD, 3D, and 4D ICE product lines for cardiac interventions.From a horizontal perspective (track layout), Ice Crystal Intelligence has laid out many interventional ultrasound tracks, including intracavitary ultrasound, such as gastrointestinal interventional ultrasound, tracheal interventional ultrasound, and urinary/uterine interventional ultrasound.

From a vertical perspective (industrial chain layout), Ice Crystal Intelligent has established the entire value chain of interventional ultrasound, including upstream key component R&D, midstream probe design and development, mainframe system and algorithm design and development, downstream AI imaging and algorithm R&D, as well as research collaboration platforms that integrate medical and engineering expertise, and even technical cooperation platforms with related surgical instruments, ultimately forming a technological closed loop.

In addition, companies such as ZePu Medical, Shenzhen HuanYing Medical, BeixCore Life, and YINGMEIDA Medical are also laying out ICE products, aiming to provide more product options for patients.