Landmark Launch: China's First Independently Developed 60MHz High-Speed IVUS System, the World’s Fastest Imaging IVUS, Hits the Market

2022Year8Month20Recently, at the 4th International Conference on Cardiovascular Medicine of “Confucianism, Taoism, and Mind-Heart Studies”(CTCC 2022)Above, InSight Lifetech unveiled its all-new generation for the first timeIVUSSystem——China’s First Self-Developed 60 MHz High-Speed IVUS Product, and the Fastest Imaging IVUS Product Globally。InSightIVUSThe system's approval for market launch will break the monopoly held by imported products and fill the gap in domestically producedIVUSMarket gap.

Meanwhile,Academician Ge Junbo's TeamApplication of InSight Lifetech’s TRUEVISION IVUS Imaging Catheter and VivoHeart IVUS Diagnostic System in Live Surgical Demonstration: Successful Guidance of CTO Recanalization During the ProcedureProfessor GrayFully leveraging the high-definition and high-speed capabilities of TRUEVISION & VivoHeart, the recanalization of a full-ostial CTO lesion in the left anterior descending artery was completed with high efficiency and superior quality. This marked the flawless execution of the world’s first live surgical broadcast following the product’s market launch!

(Professor Gray conducts a surgical demonstration using InSight Lifetech’s IVUS product)

Data shows that IVUS delivers a miniature ultrasound probe into the vascular lumen via catheterization, and then obtains clear cross-sectional images of the vascular lumen through ultrasound imaging technology. It can accurately diagnose the structure and nature of diseased vessels, guide the precise implementation of interventional surgery, and evaluate treatment outcomes.

According to reports, the product launch event will invite Zhongshan Hospital of Fudan UniversityGe JunboAcademician served as the Conference Chair and delivered the opening address, Peking University First HospitalHuo YongProfessor, Sir Run Run Shaw Hospital, Zhejiang University School of MedicineFu GuoshengProfessor, Zhongda Hospital Affiliated to Southeast UniversityMa GenshanProfessor, Shanghai Tenth People's HospitalXu YaweiProfessor, The First Affiliated Hospital of Bengbu Medical CollegeWang HongjuProfessor, The First Affiliated Hospital of Zhengzhou UniversityQiu ChunguangProfessor, The First Affiliated Hospital of USTCMa LikunProfessor, Tongji Hospital Affiliated to Tongji UniversityLiu XueboProfessor, Nanfang Hospital of Southern Medical UniversityXiu JianchengProfessor, Huadong Hospital Affiliated to Fudan UniversityQu XinkaiProfessor, Shanghai General HospitalYang WenyiProfessor, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese MedicineFan MinProfessors jointly served as conference chairs, with special invitation from Zhongshan Hospital, Fudan UniversityQian JuyingProfessor, First Affiliated Hospital of Air Force Medical University of the Chinese People's Liberation ArmyLi ChengxiangProfessor, Guangdong Provincial People's HospitalChen JiyanProfessor, Zhongshan Hospital, Fudan UniversityLi ChenguangProfessor, Shenzhen People's HospitalLiu HuadongProfessor, Co-founder and Chairman of InSight LifetechSong LiangDelivers a compelling keynote address, with special invitation extended toWuhan Asia Heart General HospitalSu XiProfessor, Huadong Hospital Affiliated to Fudan University, ShanghaiFang WeiyiProfessor, Guangdong Provincial People's HospitalZhang BinProfessorThe First Affiliated Hospital of University of Science and Technology of ChinaMa LikunProfessors and other distinguished guests served as attendees at the launch ceremony.

(Group photo of experts at the “Innovative Chips Set Sail · InSight PCI New Product Launch Symposium”)

Given the vast market potential, rapid growth rate, market landscape dominated by imported brands, and the irreversible trend of domestic substitution, we believe that InSight Lifetech’s IVUS system, as the first 60 MHz high-speed intravascular ultrasound (IVUS) system approved by the National Medical Products Administration (NMPA), will seize development opportunities in the wave of IVUS localization.

First, IVUS can help make vascular interventional diagnosis and treatment more precise, with significant room for development.In recent years, cardiovascular interventional therapy and diagnosis have been shifting toward precision. Compared with traditional devices, innovative tools such as intravascular ultrasound (IVUS) can clearly and accurately display detailed information on the lumen’s images, structure, and characteristics, thereby better guiding vascular interventional procedures.

Based on this, IVUS has been recommended for use by numerous major guidelines or expert consensuses, including the “2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention,” the “Chinese Guidelines for Percutaneous Coronary Intervention (2016),” and the “2018 ESC/EACTS Guidelines on Myocardial Revascularization.”

With the promotion of guidelines, consensus statements, and expert recommendations, the market size of IVUS has also grown rapidly. According to data released by Frost & Sullivan:In 2020, the market size of coronary intravascular ultrasound (IVUS) in China reached RMB 515 million; it is projected to reach RMB 3.48 billion by 2025 and RMB 6.43 billion by 2030.。

Secondly, China's coronary IVUS market is still in its early stages of development, with significant growth potential and rapid expansion.In 2020, only about 7% of PCI procedures in China were performed under IVUS guidance, whereas the penetration rate reached 16% in 2021, indicating extremely rapid growth. In contrast, the penetration rates in developed regions such as the United States and Europe stand at 20%, while in Japan, it exceeds 90%.Compared with mature overseas markets, there is still vast room for expansion in China.

Meanwhile, factors such as patient demand, market education, domestically produced IVUS systems, and policy support will all drive the rapid development of China’s IVUS market. For instance, there are approximately 330 million patients with cardiovascular diseases in China, and over 1.16 million percutaneous coronary intervention (PCI) procedures were performed in 2021; patients are placing higher demands on the safety, efficacy, and precision of surgical procedures; an increasing number of physicians are learning and mastering IVUS-guided interventions; and domestically produced IVUS systems have received regulatory approval... Driven by these multiple factors,The compound annual growth rate (CAGR) of China's coronary IVUS market is projected to reach 46.6% from 2020 to 2025, indicating extremely rapid growth.

Once again, China's IVUS market is currently monopolized by multinational medical device companies such as Boston Scientific and Philips.Previously, the only four IVUS products available in China were all from imported brands. Now, with the approval of InSight Lifetech’s independently developed IVUS system, domestically produced IVUS products are set to enter the market, break the monopoly held by imported products, and capture market share from foreign brands.

Finally, the localization of IVUS is an unstoppable trend. Domestically produced IVUS systems will gradually achieve import substitution by leveraging advantages such as product quality, cost-effectiveness, local adaptation, and policy support.. Therefore, as China’s first approved domestically produced 60 MHz high-definition IVUS system, the InSight Lifetech IVUS system will rapidly capture market share by leveraging its advantages in high quality and high performance, thereby increasing the domestic adoption rate of IVUS technology.

According to the introduction, the IVUS system released by InSight Lifetech consists of the VivoHeart® console and the TRUEVISION® series of catheters. It enables real-time, precise assessment of luminal dimensions and lesion plaque characteristics in coronary and peripheral vessels, thereby guiding coronary and peripheral interventional procedures. Compared with conventional procedures, vascular interventions guided by the InSight Lifetech IVUS system can reduce the incidence of major adverse cardiac events and the risk of target vessel revascularization, decrease myocardial infarction and stent thrombosis events, and enhance the precision of interventional therapy.

Notably, key components of the InSight Lifetech IVUS system, including the ultrasound transducer, interventional catheter, and software, are all independently developed by InSight Lifetech. The company has achieved innovative breakthroughs in multiple technologies, endowing its products with features such as high definition, high speed, high efficiency, and ease of use.

In terms of high definition, the InSight IVUS system employs fully self-developed ultrasound transducers, capable of providing center frequencies of 40 MHz and 60 MHz, respectively. Through comparative analysis, we have found that:A 60 MHz center frequency is a globally leading data metric, offering higher image resolution and greater penetration depth, thereby revealing more pathological details in high-definition images.。

(InSight IVUS System)

Professor Qian Juying commented, “The domestically produced new-generation InSight TRUEVISION® intravascular ultrasound catheter delivers finer and clearer image quality, enabling the visualization of more microstructures and detailed lesion features.”

In terms of high-speed aspects,The InSight Lifetech IVUS system features the world’s fastest cross-sectional imaging speed and offers four pullback speed settings to meet diverse clinical needs. Among these,Compared to the common pullback speed of 1 mm/s on the market, InSight Lifetech's IVUS achieves a maximum pullback speed of 10 mm/s.. A higher retraction speed not only significantly shortens the time required for intravascular imaging examinations but also greatly reduces complications such as vasospasm and myocardial ischemia caused by prolonged catheter dwell time in diseased vessels, thereby making intravascular imaging examinations faster, safer, and more precise.

In terms of efficiency,InSight IVUS System Features an Ultra-Long Automatic Pullback Distance, Providing Full-Vessel Lesion Visualization. Particularly for diffuse or tandem lesions, comprehensive lesion information can be obtained in a single pullback, eliminating the additional steps and time required for multiple pullbacks and mode switching, thereby enhancing procedural efficiency and optimizing workflow.

In terms of ease of use,InSight Lifetech’s IVUS system features a unique tapered shaft design that enhances catheter crossability and pushability, thereby improving the ease of use and accessibility of IVUS in complex lesions. The connector incorporates an RFID chip, enabling non-contact operation for greater precision and reliability. Additionally, the InSight Lifetech IVUS system integrates deep learning algorithms and offers excellent guidewire compatibility, facilitating procedural workflow for operators.

In summary, the InSight IVUS SystemIn terms of performanceQualityUpperLeading Globally；ClinicallySignificantly enhance the precision of interventional therapy. We believe that, leveraging its product quality advantages, InSight Lifetech will rapidly capture market share and increase the domestic production rate in the IVUS field.

Furthermore, during this launch event, InSight Lifetech also released the TrueCross® series of single-lumen microcatheters and the TrueReach® series of dual-lumen microcatheters, designed to assist guidewires in recanalizing complex lesions such as chronic total occlusions (CTO).

According to reports, InSight Lifetech’s microcatheter product portfolio features a unique shaft structure design and patented precision composite technology combining braiding and spring coils. This design delivers excellent trackability, pushability, torque response, and flexibility, providing guidance and strong support for guidewires. It facilitates the smooth passage of guidewires through complex lesions such as chronic total occlusions (CTO), thereby effectively improving the success rate of CTO procedures.

Meanwhile, InSight Lifetech also possesses the first approved domestic gold-standard FFR system. The combination of “FFR + IVUS + microcatheter” constitutes a one-stop solution for precise PCI and complex PCI.

Academician Ge Junbo stated that the coming decade will be an era defined by precision interventional guidance through coronary physiology and intravascular imaging. With exceptional craftsmanship, InSight Lifetech has launched a comprehensive solution for precise coronary intervention to support precision medicine. This portfolio includes the first pressure microcatheter for direct FFR measurement, the first domestically developed non-hyperemic physiological index technology (cRR), China’s first independently innovated 60 MHz high-speed IVUS system, the world’s only ultra-thin dual-lumen microcatheter, and the single-lumen microcatheter with the smallest outer diameter and torque capability. We look forward to seeing innovative Chinese medical devices step onto the global stage.

Leveraging numerous first-in-China or first-in-the-world products, InSight Lifetech has initially established a comprehensive solution for the precise diagnosis and treatment of vascular diseases. Its “FFR + IVUS + Microcatheter” product portfolio will also accelerate the transition of domestic vascular interventional procedures toward precision medicine.

In addition, InSight Lifetech offers product lines such as the Shockwave Balloon Therapy System for precise diagnosis and treatment, as well as electrophysiology solutions. Combined with its existing portfolio—including FFR, IVUS, and microcatheters—InSight Lifetech’s innovative product suite supports precision diagnosis and therapy for multiple conditions affecting the coronary arteries, peripheral vessels, and atrial fibrillation. Perhaps due to its innovation and rapid product commercialization, the company is recognized as a leader in precision interventional cardiovascular solutions.