Breakthrough Launch: China's First Independently Developed 60MHz High-Speed IVUS System Receives NMPA Approval
On July 27, the intravascular ultrasound (IVUS) diagnostic system independently developed and manufactured by Shenzhen Northcare Medical Technology Co., Ltd. (hereinafter referred to as “Northcare”) obtained the Class III medical device registration certificate from the National Medical Products Administration (NMPA). This is not only China’s first self-developed 60 MHz high-speed IVUS product, but also the fastest-imaging IVUS product currently available worldwide.
Innovative Medical Devices · National Key R&D Program of the Ministry of Science and Technology
Intravascular ultrasound (IVUS) delivers a miniature ultrasound transducer into the vascular lumen via catheter-based technology. Through high-density spiral scanning, it clearly obtains cross-sectional images of the entire vascular lumen and vessel wall, thereby intuitively assisting interventional cardiologists in comprehensively and accurately diagnosing the structure and nature of stenotic lesions, guiding the precise implementation of interventional procedures, and enabling more thorough assessment of treatment outcomes. Together with fractional flow reserve (FFR), IVUS constitutes the imaging and physiological toolkit that guides precision therapy in contemporary percutaneous coronary intervention (PCI) for coronary artery disease.
Northcore IVUS products by VIVOHEART®Host and TRUEVISION®The catheter series consists of two components, featuring the industry’s highest imaging resolution (60 MHz ultrasound imaging frequency), the world’s fastest imaging speed (100 frames per second for cross-sectional imaging; 10 mm/s pullback speed), the inSmartVision high-performance image analysis platform, and superior catheter maneuverability. It rapidly and efficiently provides comprehensive intravascular images and detailed lesion information, guiding the implementation of precise coronary interventional therapy.
From receiving support under the Ministry of Science and Technology’s National Key R&D Program—Special Project on the Development of Digital Diagnostic and Therapeutic Equipment, to entering the National Innovative Medical Device Approval Pathway, and ultimately obtaining market approval for its final product, Northcore has spent five years honing its expertise, steadfastly advancing with the mission of improving life and health through innovation and quality.
1. High Definition
Northcore TRUEVISION®Series of catheters featuring fully self-developed ultrasound transducers; the 60 MHz center frequency delivers high-definition images for clinical users, revealing more microstructures and lesion details; it also supports a 40 MHz center frequency, providing additional options to meet diverse clinical application needs.
2. High Speed
Northcore Intravascular Ultrasound Imaging System: Up to four pullback speed settings accommodate diverse clinical scenarios. With a maximum imaging frame rate of 100 fps, it delivers dense longitudinal scanning to ensure no minute lesion details are missed. At the fastest pullback speed of 10 mm/s, acquiring lesion information over a 150-mm length takes only 15 seconds. This significantly reduces intravascular imaging examination time while substantially lowering procedural risks associated with prolonged catheter dwell time in diseased vessels, such as vasospasm and myocardial ischemia, thereby making intravascular imaging faster and safer.
3. High Efficiency
NorthCore TRUEVISION®The series of catheters features an ultra-long pullback distance of 150 mm. The lesion visualization range covers the entire vessel, particularly for diffuse or tandem lesions. All lesion information can be obtained in a single pullback, eliminating the additional steps and time required for multiple pullbacks and switching between operation modes, thereby improving procedural efficiency and optimizing the surgical workflow.
4. Ease of Use
The rapid-exchange design and excellent guidewire compatibility, combined with a unique tapered shaft design, provide the catheter with superior trackability and pushability, enhancing the ease of use and adoption of IVUS in complex lesions. The connector features a built-in RFID chip, enabling non-contact operation for greater system precision and reliability.
5. Intelligence
InSmartVision High-Performance Image Analysis Platform automatically identifies lumen and EEM boundaries, calculates plaque burden, and intelligently processes lesion images to identify the minimal lumen area, assisting operators in precise and rapid image interpretation while reducing the difficulty and time required for treatment strategy decision-making.
To date, there has been a substantial body of research on the improvement of clinical outcomes with intravascular ultrasound (IVUS). The ADAPT-DES study is the largest prospective, multicenter, non-randomized study to date evaluating IVUS-guided stent implantation. It enrolled 8,582 patients from 11 clinical centers in the United States, including 3,362 in the IVUS-guided group and 5,221 in the angiography-only group. Two-year follow-up results demonstrated that IVUS use optimized percutaneous coronary intervention (PCI) strategies in 74% of cases, reduced the incidence of major adverse cardiac events by 28%, myocardial infarction by 35%, and stent thrombosis by 60%.1。
The ULTIMATE study is the largest prospective, multicenter, randomized controlled clinical trial of intravascular ultrasound (IVUS) in China. It enrolled 1,448 Chinese patients, who were randomly assigned to either an IVUS-guided group or an angiography-guided group. The results showed that the one-year incidence of the primary clinical endpoint, target lesion failure, was 2.9% and 5.4% in the two groups, respectively, with a statistically significant difference between them. This indicates that IVUS guidance reduced the incidence of target vessel failure (TVF) by 46.3%.2。
Furthermore, a meta-analysis incorporating eight randomized controlled trials on DES demonstrated that IVUS-guided DES implantation reduces the risk of MACE by 36% and the risk of TVR (target vessel revascularization) by 40%.3。
Today, IVUS has become an indispensable tool in PCI procedures and has been incorporated into relevant clinical guidelines and expert consensus statements issued by countries and regions such as Europe and China due to its clinical value.4,5,6. As Chinese clinicians gain a deeper understanding of IVUS application scenarios, IVUS is poised to become a widely adopted tool for guiding precision interventional therapy for coronary heart disease in China.
1、Ahn JM, Kang SJ, Yoon SH, et al. Meta-analysis of outcomes after intravascular ultrasound-guided versus angiography-guided drug-eluting stent implantation in 26,503 patients enrolled in three randomized trials and 14 observational studies. Am J Cardiol. 2014; 113(8), 1,338-47
2、Zhang J et al. Intravascular Ultrasound Versus Angiography-Guided Drug-Eluting Stent Implantation: The ULTIMATE Trial. Journal of the American College of Cardiology .2018 Dec 18; 72(24),3126-3137
3、Hong SJ, Kim BK, Shin DH, et al. Effect of intravascular ultrasound-guided vs angiography-guided everolimus-eluting stent implantation: the IVUS-XPL randomized clinical trial. JAMA. 2015;314(20):2155-2163.
4、Räber L, Mintz GS, Koskinas KC, et al. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. European heart journal 2018, 39(35): 3281-3300.
5、FJ Neumann, M Chettibi, H Sisakia, et al. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J, 2019
6. Chinese Guidelines for Percutaneous Coronary Intervention (2016)
To date, Northcore has established a one-stop solution for precision and complex PCI, featuring a product portfolio of “FFR + IVUS + microcatheters.”
Founded in 2015, Northcore is China’s first and only national high-tech enterprise to offer a combined portfolio of intravascular functional and imaging products for cardiovascular applications. The company has assembled a team of over 100 outstanding researchers and senior industry experts from both domestic and international backgrounds. It operates more than 7,000 square meters of R&D and manufacturing facilities, including three GMP-compliant production workshops. Northcore holds over 100 patents and has more than 200 patent applications pending. Its independently developed and manufactured products have been adopted by over 500 hospitals in China and are exported to numerous countries and regions worldwide, including Belgium, Germany, Italy, and Spain.
NorthXin is committed to building a world-class innovation platform for active interventional medical devices. It has established three core foundational platforms—interventional catheters, micro-nano devices, and high-performance medical electronic software and hardware—driven by technology and guided by market demands. By forging long-term collaborations with leading hospitals in China and renowned cardiovascular experts both domestically and internationally, NorthXin provides the impetus for continuously translating cutting-edge scientific technologies and clinical value needs into innovative product development. Dedicated to delivering solutions that combine innovation and quality for patients and healthcare providers worldwide, NorthXin strives to become a globally influential medical technology enterprise.