Source of the article: Heart Future; Editor: Bai Xiaofei
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently,General Hospital of Northern Theater Command, PLAUnder the leadership of Academician Han Yaling, the cardiology department, led by Professor Wang Zulu's electrophysiology expert team, usedSonosemi Medical Co., Ltd.(abbreviated as "SONOSEMI")Intracardiac Ultrasound Imaging System("ICE System")SuccessFor Two Patients with Atrial FibrillationCompleted ICE-guided cardiac interventional treatment surgery。This is the first domestically-developed ICE system in China after its market launch.World's First Clinical Applications, marking the first two clinical applications in the entire military.SONOSEMIIndependently DevelopedIntracardiac Ultrasound Imaging SystemIn July 2024Officially Approved for Marketing by the National Medical Products Administration (NMPA), becomingThe First Complete Set in China(Catheter + Host) Approved as a Domestically Produced ICE System After Entering the Innovative Green Channel。The system hasGreater Detection Depth，Not only suitable for all conventional cardiac interventional surgeries, but also capable of optimizing the operation of left atrial appendage closure under intracardiac echocardiography guidance., improved surgical efficiency and reduced complications.
Professor Jin Zhiqing of the expert team is performing the surgery.
# Patient and Surgical DetailsCase One: The patient is a 72-year-old male, admitted with a diagnosis ofPersistent atrial fibrillation, poor anticoagulation effect in patients, and high stroke and high bleeding risk.After full communication with the patient and their family, Professor Ding Jian decided to perform a left atrial appendage closure procedure on the patient, considering the patient's advanced age.To avoid the risks of general anesthesia, the SONOSEMI ICE system was used to ensure the safety of the surgery.。Case Two: The patient is a 68-year-old female, admitted with a diagnosis ofPersistent Atrial Fibrillation。After full communication with the patient and their family, Professor Jin Zhiqing decided to proceed with the treatment for the patient.Atrial Fibrillation AblationIn order to ensure patient safety and the smooth progress of the surgery, the SONOSEMI ICE system was used to assist in the operation.Professor Zulu WangIntracardiac echocardiography (ICE) is a "powerful tool" for clinicians to perform cardiac interventional procedures. The domestically developed ICE system by SONOSEMI Medical can clearly observe the relationship between the atrial septum and the left atrial appendage, offering significant assistance in thrombus screening, determination of puncture sites, assessment of catheter coaxiality, and monitoring of complications.Can better guide atrial fibrillation ablation, left atrial appendage closure and other cardiac interventional procedures.。
▲Source: SONOSEMI MedicalSONOSEMI Intracardiac Ultrasound Imaging SystemByDynaSight®Single-Use Intracardiac Ultrasound Imaging Catheter(China Medical Device Registration: 20243061274) andUDG3900 Series Portable Ultrasound Diagnostic System(China Medical Device Registration: 20243061271) Composition.The system through its ICE catheter tipEnd-Miniature Phased Array ProbeContinuously emit ultrasound signals and receive echoes, the anatomical structure within the heart chambersPerform real-time, high-quality imaging, which is an important auxiliary method in cardiac interventional therapy.Portable Ultrasound Diagnostic DeviceComposed of an ultrasound host, connector, and power adapter.Single-Use Intracardiac Ultrasound Imaging CatheterComposed of the catheter tip, deflectable tube, control handle, and rear connector.UtilizeInverse Piezoelectric EffectConvert the pulse electrical signal output by the portable ultrasound diagnostic device into ultrasound waves and emit them into the intracardiac tissue., and receive the echo signal transmitted to the portable ultrasound diagnostic instrument, which is then converted into a digital image signal and displayed on the monitor.
The above two products are used together for ultrasonic imaging of the adult heart, major cardiac vessels, and intracardiac anatomical structures.Compared with similar products, it has a larger detection depth and is the first intracardiac ultrasound imaging system in China.。
The superior performance of this ICE system product manufactured in China has been highly praised by clinical experts in the DISTINCT clinical trial.All indicateThe overall performance, such as catheter maneuverability and image quality, has reached and partially exceeded the level of similar imported products.。# First Clinical Enrollment
February 2023,Shanghai Chest HospitalProfessor He Ben Led the Team to Successfully CompleteSONOSEMI Intracardiac Echocardiography Imaging System (ICE)First Patient Enrolled in China for Pre-Market Registration Clinical Trial, which marks that the project led by Professor He Ben as the Principal Investigator (PI) and Professor Chu Huimin from Ningbo First Hospital as the Co-Principal Investigator (Co-PI)China's First Domestically Produced ICE Prospective, Multi-Center Registration Clinical Trial Officially LaunchedThis breakthrough is a key milestone for the field of intracardiac ultrasound imaging in China, marking the transition from technological development to clinical practice.
▲Source: Shanghai Chest HospitalThe patient is a 66-year-old male who was admitted to the hospital due to "paroxysmal palpitations for more than 10 years, recurring for 1 month." One month prior, the patient experienced a recurrence of palpitation symptoms, which were more severe than before. The electrocardiogram indicated atrial flutter.The preliminary diagnosis was arrhythmia, atrial fibrillation and flutter, hypertension, and sequela of cerebral hemorrhage.，Plan to perform left atrial appendage closure under intracardiac ultrasound imaging guidance after completing catheter ablation.。After thorough preoperative assessment and preparation, Professor He Ben led the team members, Professor Jiang Lisheng, Dr. Hao Ziyong, and Dr. Fan Yiting.Ultrasound-Guided Left Atrial Appendage Occlusion Performed Using SONOSEMI's ICE System。Intraoperatively, the ICE catheter viaFemoral Vein ApproachDelivered to the patient's right atrium, throughCatheter Bending Adjustment AcquisitionAnd provided ultrasound images of related anatomical structures within the heart chambers, clearly showing cardiac anatomical structures such as the right atrium, right ventricle, tricuspid valve, atrial septum, left atrium, left atrial appendage, left ventricle, and mitral valve. Blood flow assessment and measurement of the left atrial appendage were completed through echocardiography.Under the guidance of ICE, the left atrial appendage occluder was successfully deployed in one go.. Real-time echocardiography showed after the operationThe occluder was perfectly positioned with an ideal sealing effect, and the surgery was successfully completed.。# Development Overview of ICE Made in China
Intracardiac Echocardiography (ICE) is aFusion of Phased Array Ultrasound Imaging and Cardiac CatheterizationPercutaneous vascular interventional ultrasound imaging technology. ICE hasReal-time ultrasound imaging, unrestricted by imaging windows, and well-toleratedAnd other advantages, only need to during the surgery implementation processLocal anesthesia, flexible bending operation, full visibility under ultrasound imaging, helping clinicians obtain the anatomical structure within the heart chambers, monitor intraoperative complications in real time, and perform Doppler flow assessments.
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. As the application range of ICE technology becomes wider,ICE Catheters Gradually Become the "Golden Eye" for Cardiac Interventional Doctors。
As a technology with the "green" procedural gene, ICE technology can help cardiac interventional doctors perform atrial fibrillation radiofrequency ablation, atrial septal puncture, left atrial appendage closure, PFO foramen ovale closure, and other cardiac interventional treatments more precisely.Reduce operation time and surgical complications, significantly decrease the use of X-rays and contrast agents, while also reducing the need for coordination with anesthesiology and ultrasound departments, helping medical institutions further optimize overall operational efficiency.。
In recent years, ICE has been increasingly applied inIntraoperative Monitoring for Cardiac Electrophysiology Treatment, Minimally Invasive Valve Disease Treatment, Cardiac Pacing Treatment, and Congenital Heart Disease Occlusion Treatmentand other fields, while also playing an increasingly important role in the preoperative diagnosis of complex structural heart disease.The most maturely applied field at present is arrhythmia.Traditional electrophysiological treatment mainly relies on X-ray fluoroscopy and electrophysiological mapping catheters for positioning. Due to the inability to fully and clearly provide the internal anatomical structure of the heart, it is prone to perioperative complications such as cardiac tamponade and pulmonary vein stenosis, with a relatively high recurrence rate. ICE can place the catheter probe in the right atrium or right ventricle, providing real-time clear images of the left atrium, left ventricle, and the opening of the pulmonary veins, allowing surgeons to precisely locate ablation targets.Currently, there are mainly 3 imported ICE products (from Johnson & Johnson, Abbott, and Siemens) and 1 domestically produced ICE product (by TingSheng Technology) approved in China.Chinese manufacturers' ICE is mostly in the research and clinical stages, with a focus on 2D products. 4D ICE has extremely high technical barriers, and few manufacturers in China have truly started to lay out their strategies.
TingSheng Technology——China's First Self-Developed ICE Catheter
AsThe first domestically produced intracardiac echocardiography diagnostic catheter approved in China (November 2023),TingSheng TechnologyThe TINGSN Sonic Eyes 10, consisting of a catheter body, an operating handle, and a connector, is used in conjunction with the company's portable color ultrasound diagnostic system. It is suitable for medical institutions to perform ultrasound imaging of the heart, major cardiac vessels, and intracardiac anatomical structures.
▲Intracardiac Ultrasound Diagnostic Catheter and Portable Color Ultrasound Diagnostic System
The product features four-way bending control, segmented design, real-time temperature detection, and multi-frequency switching between 4.5MHz and 9.5MHz. Currently, Tingsheng Technology alsoCompleted the development of real-time 4D intracardiac echocardiography catheter (4D ICE), and successfully completed the research and development and manufacturing of the world's third commercialized intracardiac ultrasound ASIC chip.This ASIC chip can be used for the design and integration of probes related to intracavitary ultrasound and transesophageal ultrasound.It is the first and currently the only commercialized ASIC chip with independent intellectual property rights for intracardiac ultrasound in China.TingSheng Technology's real-time 4D intracardiac echocardiography (4D ICE) product is expected to be officially put into clinical use in 2024.CardioViz Tech——World's Thinnest ICE Catheter SizeCardioViz Technology currently has 2D and 4D ICE products.Among them, the 2D ICE system has the thinnest ultrasound catheter size in the world., approaching the industry's technological limits, will help minimize complications caused by puncture injuries and provide patients with a high-quality ICE solution made in China. Currently, this systemHas entered the registered clinical trial stage。
▲4D ICE Catheter
4D ICE SystemIntegrated with advanced technologies such as soft beamforming, arbitrary waveform transmission, and more.，Supports dynamic 3D display of cardiac structures and 2D imaging of arbitrary planes, with flexible and convenient operation (bending radius ≥120°), a broad imaging field of view (≥90°x 90°), and high 4D frame rates, ensuring efficiency and precision during interventional procedures.Effectively reduce the risk of cardiac interventional surgery and shorten the learning curve for operators.TheThe system has completed clinical enrollment.In animal experiments, the three-dimensional structures such as the atrium, ventricle, and valves are clearly and dynamically visible in real time, achieving excellent imaging results. The system's reliability, effectiveness, and safety have been further validated.
IceCrystal Technology——Full-line Layout of ICE ProductsIce Crystal Intelligence is one of the few in ChinaFull-line Layout of 2D, HD, 3D, 4D ICE Product Series for Cardiac Interventionsmanufacturers. To meet the usage requirements of different clinical scenarios, the company has developed the next generationHigh-Definition High-Speed Intracardiac Echocardiography HD-ICE. The product adopts the industryInThe World's First Next-Generation Acoustic Energy Conversion System, which can effectively improve signal acquisition, transmission efficiency, and image clarity; at the same time, the HD-ICE system adoptsChina's First Dedicated High-Definition Cardiac Image Processing System, utilizing the latest algorithm technology in the industry, offers faster imaging speed, thereby meeting more clinical needs.▲Company Related Product LinesIn the 4D ICE field, Ice Crystal Intelligence adopts the internationally mainstream electronic matrix transducer technology solution and correspondingly uses a high-speed volumetric reconstruction algorithm. This solution has advantages over mechanical volumetric imaging solutions.Significant Advantage of High Imaging Rate, canMore Real-time Observation of Heart Valve Movement, which has a natural advantage for procedures with extremely high real-time requirements, such as mitral valve clipping.The company has developed relevant test samples and is currently preparing for animal experiments.。SONOSEMIFounded in April 2020, headquartered in Shenzhen, is a research and productionActive Vascular Implantable Medical Deviceshigh-tech enterprise, with main businesses coveringCardio-cerebrovascular, Peripheral VascularIn the medical field represented by, the products includeShockwave Balloon Catheter, Ultrasonic CatheterSuch as active interventional high-value medical consumables, the products coverCoronary artery disease, peripheral vascular disease, and structural heart diseaseIn the clinical fields of cardiovascular and cerebrovascular diseases.SONOSEMI has broken through the technical barriers of high-end medical devices overseas and independently developedCoronary Intravascular Shockwave Therapy System, Peripheral Arterial Intravascular Shockwave Therapy System, Intracardiac Ultrasound Imaging System, Intravascular UltrasoundSuch as innovative products in the field of active vascular intervention,A product matrix consisting of 4-6 products is expected to be formed by the end of 2024., providing customers with comprehensive and integrated solutions.These products extensively cover indications such as coronary artery calcification, peripheral artery calcification, aortic valve stenosis, and structural heart disease.As of the date of this report, the company's financing history is as follows:
According to Tianyancha information, the actual controller of SONOSEMI is Liu Bin.SONOSEMI's co-founder and CEO, previously worked at Huawei Technologies, isHuawei EngineerBackground. With many years of experience in communication and semiconductor technology research and applications, he has a strong technical background in the industry and holds more than 20 invention patents. He is also a serial entrepreneur with extensive experience in technological innovation, team management, and commercial applications.Participated in the entrepreneurship of a semiconductor chip company, and through in-depth collaboration with partners in the medical field, successfully advanced the shock wave balloon—an active interventional product—into the clinical stage. A series of interventional visualization hardware products developed by the company will also obtain certifications successively thereafter. The company’s platform-based development strategy is very clear.
