Boston Scientific Launches First AI-Enabled IVUS System AVVIGO+ in China

Coronary heart disease is one of the most common and harmful diseases among middle-aged and elderly people, and with the change of unhealthy lifestyle, the trend of its incidence begins to spread to the younger population.

Common angiographic methods for diagnosing coronary heart disease only use X-rays for two-dimensional imaging, which cannot accurately display the structure of the vessel walls and details of hardened areas. Moreover, due to the need for precise images, doctors must perform auxiliary imaging by changing angles, making the operation more difficult.

AndIntravascular Ultrasound (IVUS) Technology is Mainly Based onUltrasound Imaging and Minimally Invasive Catheter Technology，Using a catheter equipped with an ultrasound probe for three-dimensional imaging in tissues, it is able to display detailed images of vascular cross-sections, cavity walls, and plaques.，Not only can it help doctors accurately assess the nature of lesions, but it can also provide real-time guidance during interventional treatment, increasing the success rate of surgery.。

Therefore, since its introduction in 1989, IVUS has gradually become the "gold standard" for intravascular imaging examination of coronary artery disease.

In fact, imaging within narrow and tortuous blood vessels places extremely high demands on catheter design. On the one hand, it must resist signal interference to ensure clear imaging; on the other hand, it needs to accommodate the bending and rotation of small vessels. Faced with this technical challenge, many medical device manufacturers have stumbled.

Boston Scientific has extensive experience in the field of vascular intervention.Is the world's first company to launch an IVUS diagnostic technology product., occupying the second largest market share in the global intravascular ultrasound market.

In October this year, Boston Scientific's AVVIGO+ officially debuted in China,As early as 2023, Boston Scientific's AVVIGO+ Intravascular Ultrasound System received consecutive approvals from the FDA and CE., and has won widespread recognition in overseas markets. The rapid advancement of commercialization is inseparable from the technical leadership of AVVIGO+.

From the initial iLab intravascular ultrasound system to today's AVVIGO+, through layers of iteration,Boston Scientific not only overcomes the design challenges of imaging catheters but also pioneers the use of AI for assisted diagnostic evaluation., effectively improving diagnostic efficiency.

The disposable imaging catheter (probe) is the most important component of IVUS, where the key to imaging lies in the transducer capable of emitting and receiving high-frequency ultrasound waves. AVVIGO+ usesOPTICROSS HD Coronary Imaging Catheter, Equipped with a 60MHz Transducer Frequency, breaking through the previous limit of 45Hz.

Compared with IVUS images obtained using low-frequency ultrasound, the images recorded at 60 MHz are clearer. Additionally, due to the shorter wavelength, interference signals caused by excessive penetration can be avoided, effectively displaying the vascular structure at close range.

(Image source: Boston Scientific official website)

According to BSC benchmark data, the minimum axial resolution of the OPTICROSS HD imaging catheter is 22μm.The delivery capability is 46% to 68% higher than that of the Philips Volcano IVUS catheter (45MHz, 50μm).. Compared with Abbott's Optical Coherence Tomography (OCT) technology, it hasEquivalentResolution, low contrast usage rate, and better depth.

In addition to upgrading on the hardware foundation, AVVIGO+ provides operators with an AI-based automatic lesion evaluation function in terms of software.

ThroughAssisted by a vast array of machine learning and AI algorithms，ALA system automatically provides key measurements in the final imaging stage, including accurate lumen diameter and vessel boundaries, as well as distal, proximal, and minimal keyframe markers, etc.. In addition,The system integrates the Fractional Flow Reserve (FFR) for assessing blood flow and the Diastolic Flow Ratio (DFR)., Quantitative measurements provide intuitive anatomical characteristics and physiological function data of stenotic lesions, offering precise basis for diagnosis and treatment plans.

It is reported that the AI system is also equipped with a 7-level quick callback function, which can achieve automatic pull-back with simple operation.Speed up to 8mm/s, which can reduce operation time by 62% compared to the previous generation system.

In this regard, the person in charge of Boston Scientific's Coronary Intervention and Structural Heart Valve Division in China, as well as the technical exploration, stated that in the past 30 years, the IVUS diagnostic system has undergone three major upgrades. The first-generation system was introduced into China at the end of the 20th century.The second-generation system has achieved localized production in China.. We are pleased to see that the latest generation of AVVIGO+ developed with the deep involvement of a Chinese team has been officially approved in China.

As mentioned earlier, the new generation of AVVIGO+ is not the first localized product to be launched. Cutting-edge products and technologies continue to take root in China. Why is Boston Scientific focusing on the intravascular ultrasound niche in the Chinese market?

The next two data will provide the answer.

Cardiovascular diseases (CVD) have consistently been not only the leading cause of death globally but also the primary cause of mortality in China. Data from the NCCD indicates that the number of CVD cases in China is on a continuous rise, with an estimated 330 million people affected.Among them, coronary heart disease accounts for 34%.。

Coronary heart disease is mainly caused by atherosclerotic lesions in the coronary arteries, leading to vascular stenosis and blockage. In addition to drug treatment, the current mainstream treatment method is to use balloons or stents for vascular expansion, namely interventional treatment (PCI).

As a more advanced intravascular imaging method, IVUS has become an indispensable part in early diagnosis, guidance for surgical treatment (including stent size and position), and postoperative evaluation and follow-up, driven by advancements in treatment techniques and the needs of clinical diagnosis.

According to Sullivan data, the application proportion of IVUS in PCA surgery in China was only 8% in 2019.Increased to 15% in 2022, the clinical penetration rate is far from saturated.

WithThe Prevalence of Cardiovascular Diseases,Clinical value is becoming increasingly prominentIVUS MarketGrowthThe main driver.

In 2023, the市场规模 of IVUS in China was approximately 3.05 billion yuan, and GII data predicts,It is expected to reach 6.69 billion yuan by 2030, with an annual compound growth rate of 17%.。

In addition to cardiovascular disease diagnosis, IVUS, as a clinical subdivision of ultrasound equipment, is increasingly favored by more doctors and patients for its minimally invasive feature that does not require high-intensity invasive surgery.Riding the Wave of Minimally Invasive Surgery PopularityThe application prospect of IVUS technology can be said to be very bright.

On the other hand, in recent years, the IVUS field has seen advancements in equipment transducer upgrades and algorithm software, among other areas.Technological Breakthrough, enhancing the availability and accuracy of the equipment, making intravascular ultrasound devices the first choice for clinical treatment, and further expanding their market coverage.

Under the new development pattern,VastThe Chinese medical device market is growing rapidlyEvolution。

Thanks to the transformation and upgrading of the manufacturing industry, " localization" has become a buzzword in the medical device industry, with numerous local enterprises flooding into the innovation track.Currently, more than 8 companies have received approval for their IVUS-related devices to be marketed.。

The approval of domestically produced products marks an important step in breaking the monopoly of imported products, while the implementation of centralized procurement has accelerated this process.

Especially in the highly concentrated intravascular ultrasound market, the centralized procurement has directly cut half of the market. For example, in the provincial alliance centralized procurement in March this year, the average price reduction for IVUS device catheters was...Over 50%。

For Boston Scientific, the rise of domestically produced (Chinese-made) products is evident:From 2022 to present,Nearly 20 IVUS diagnostic-related products have强势"dominated" the rankings.，Chinese brands start to step on the gas in their quest for a breakthrough。

Taking MicroPort Medical as an example, itsMinimally Invasive TraceDeveloped IVUS Diagnostic DeviceDecypher™ and Outsight® Single-Use Catheter, to40mm/sRetract speed breaks the limit of similar products in the industry,The minimum resolution can reach 20μm., which was approved for marketing in October this year.

In the same month,Over 100MHzDual-frequency Intravascular Ultrasound SystemDebut，Imaging frequency far exceeds that of Boston Scientific's new generation products, According to reports, the system isShenzhen Institute of Advanced Technology collaborates with Shenzhen Haoying Medical, Huitai Medical, and the National Innovation Center for High-Performance Medical DevicesJointly developed, with a total of 50 clinical trials completed to date.

As early as 2022,Panorama Hengsheng's Global First IVUS-OCT Dual-Technology Vascular Fusion Imaging Device Approved。

Not long after,Innvo Medical, Northcore Life, Sonoscape Healthcare, Tianjin HengyuSuccessively launched disruptive IVUS diagnostic products, providing more diverse options for the treatment of coronary heart disease.

From domestic bloodExamination of the IVUS Market Competitive Landscape, Boston ScientificNew GenerationAVVIGO+The commercialization path in the Chinese market is not easy. In addition to withstanding the impact of hospital centralized procurement, it is also necessary to compete with locally produced medical device companies that have more price advantages, presenting considerable challenges.

However, standing at the crossroads of a new market cycle,Keep Moving ForwardDeep LocalizationStrategy, a crucial move for Boston Scientific to reverse its fortunes。

In the technology research and development process, Boston Scientific not only intensifies the introduction of revolutionary interventional treatment technologies but also enhances local innovation competitiveness by establishing research and development centers and engaging in multi-dimensional cooperation with Chinese local enterprises.

From 2023 to present, Boston Scientific has focused on development, technology transfer, and pipeline expansion.Strategic cooperation with Cercor and NeoScope MedicalThe former is an innovative medical device company with strong momentum in the Hong Kong stock market, and the latter has a world-leading level in the 3D endoscope field. Currently, Boston Scientific's R&D team in China has expanded to more than a hundred people.

In the production and manufacturing process, Boston Scientific's operations in China continue to extend upstream and downstream along the product value chain. In October this year,First Manufacturing Base in China Opens in Shanghai, the factory is equipped with an innovation laboratory and a digitally managed warehouse, which can shorten the time from manufacturing to end sales. Previously, the intravascular ultrasound system Polaris has achieved localized production in China.

In addition, in the field of clinical precision treatment, Boston Scientific has joined hands with this hospital and institute to establishInnovative Treatment Center, providing clinical application and data support for the incubation of cutting-edge technology products.

It is not hard to imagine that, with the deepening of localization, a new market growth engine will soon be built. From Polaris to AVVIGO+, the story of Boston Scientific and the Chinese market will continue.

There is no denying that, even under strong policy guidance, the medical device industry still requires enterprises to possess irreplaceable comprehensive competitive strength. WeThe Competition in the IVUS Field Reveals Changes in the Market Landscape, with Boston Scientific's AVVIGO+ Product as a Typical Representative of a Foreign Brand Produced in China.Narrowing the Price Gap with Localized Production，A Signal Worth Warning for Chinese Brands。

But on the other hand, this also points the way for domestic companies: how to take advantage of policy support to further...Enhance product innovation capabilities and industrial chain collaboration capabilities, in the promising field of intravascular ultrasound, breaking through the competition has become a pressing issue to consider.