Bolik Medical Redefines IVUS Value with Single-Pullback Morpho-Functional Assessment System

In recent years, significant technological advances have been made in FFR (Fractional Flow Reserve) and IVUS (Intravascular Ultrasound) for the diagnosis of cardiovascular diseases.

By leveraging fractional flow reserve (FFR), physicians can achieve precise functional assessment of coronary stenosis in the diagnosis of coronary artery disease, thereby reducing unnecessary stent implantation. Intravascular ultrasound (IVUS) provides clear imaging of target vessels, enabling real-time qualitative and quantitative analysis of lesion severity, which helps clinicians more accurately assess plaque risk and optimize surgical decision-making.

Multiple previous clinical studies have demonstrated that functional and imaging assessments are not interchangeable. The combined assessment using FFR and IVUS can be applied to various complex lesions, thereby improving patient outcomes. However, performing combined IVUS and FFR assessments requires the simultaneous use of two separate sets of equipment and consumables. This not only complicates the surgical procedure but also imposes a greater financial burden on patients, failing to meet the basic requirements of health economics.

To overcome clinical limitations, Pulse Medical Imaging Technology has independently developed the Ultrasound Fractional Flow Reserve (UFR, IVUS-based FFR) and the next-generation IVUS system “AcoPilot,” integrating IVUS with FFR.

UFR is the world’s first wire-free, IVUS-based FFR calculation system for coronary functional assessment and PCI procedural planning. With a single catheter pullback, the system simultaneously acquires both morphological and functional physiological information of the lumen. AcoPilot, powered by AI, enables one-click segmentation and calculation across entire image sequences, thereby enhancing IVUS analysis efficiency and shortening the learning curve for physicians.

At the 18th Oriental Congress of Cardiology (OCC-WCC) recently held in Shanghai, numerous clinical experts gathered at the “Seminar on Clinical Applications of Functional IVUS: Ji You Xin Sheng,” where they engaged in in-depth discussions on Acopilot, a functional IVUS system, further elucidating the value and potential of Pulse Medical’s innovative technologies.

Pulse Medical Imaging’s Functional IVUS (Acopilot) Unveiled at the 18th Oriental Cardiology Conference

In clinical diagnosis and treatment, it is difficult to find a perfect solution that obtains comprehensive information about the patient’s condition while ensuring cost-effectiveness and patient safety. Therefore, physicians make trade-offs based on the individual patient’s circumstances during the initial diagnostic phase, selecting a relatively optimal diagnostic approach.

Currently, as the two representative methods for functional and morphological assessment of coronary arteries, fractional flow reserve (FFR) and intravascular ultrasound (IVUS) have been extensively validated by numerous randomized controlled trials (RCTs) to demonstrate superior clinical outcomes compared with coronary angiography (CAG), and are now widely used in clinical practice.

So, is there value in a joint assessment of the two?

A study published in the New England Journal of Medicine investigated the guiding value of fractional flow reserve (FFR) and intravascular ultrasound (IVUS) for percutaneous coronary intervention (PCI). The study enrolled 1,682 patients with moderate coronary artery stenosis (estimated at 40%–70% by coronary angiography [CAG]) who were undergoing pre-PCI assessment. Patients were randomly assigned in a 1:1 ratio to undergo either FFR-guided or IVUS-guided PCI. The primary endpoint was a composite of death, myocardial infarction, or revascularization at 24 months after randomization.

The study results showed that the PCI rates in the FFR and IVUS groups were 44.4% and 65.3%, respectively. At 24 months, primary endpoint events occurred in 8.1% of patients in the FFR group and 8.5% of patients in the IVUS group.

In other words,FFR-guided PCI is non-inferior to IVUS-guided PCI. FFR-guided PCI resulted in fewer stent implantations and shorter duration of dual antiplatelet therapy, with similar rates of successful stent deployment and clinical events between the two groups.

If we look only at the results, we might intuitively assume that FFR-guided PCI offers greater value. After all, FFR reduces stent implantation by 10%, thereby saving patients a considerable amount of money.

However, for many specific patient populations, physicians may favor interventional therapy to prevent further clinical deterioration. For instance, elderly patients with impaired hepatic and renal metabolic function, as well as those identified by intravascular ultrasound (IVUS) as having high-risk vulnerable plaques, may derive greater clinical benefit from interventional treatment. Furthermore, in cases where fractional flow reserve (FFR) values fall within the gray zone, subsequent IVUS examination may lead to different therapeutic strategies; the combined guidance of both modalities can significantly reduce adverse events.

Although IVUS-guided PCI resulted in a 10% increase in stent implantation, it did not increase the rate of MACE events. Furthermore, it compensates for the limitations of angiography by facilitating a comprehensive understanding of plaque morphology and guiding stent selection.

Overall, FFR and IVUS each play distinct roles and offer unique advantages in guiding PCI. Therefore, when addressing the questions of whether to intervene and how to proceed with treatment, combined guidance using FFR and IVUS undoubtedly provides more reliable answers.

And now, Pulse Medical has combined the functions of both.

According to Pulse Medical Imaging Technology, AcoPilot quantifies collateral ostia and automatically delineates lumen contours to reconstruct the reference lumen, then performs hemodynamic calculations to derive the UFR value. This achieves, for the first time internationally, the simultaneous assessment of plaque morphology and coronary physiology. The initial clinical validation results of this product were selected as a Late-Breaking Clinical Trial (LBCT) presentation at the 2020 EuroPCR conference and have recently been accepted for publication in Circulation: Cardiovascular Interventions, a prestigious subspecialty journal of Circulation focused on interventional cardiology.

Clinical validation results demonstrated a strong correlation and agreement between UFR and FFR (r=0.87; p<0.001). The concordance between UFR and FFR was independent of lesion location, prior myocardial infarction, and imaging catheter type. Using the conventional FFR cutoff value of 0.80 to determine the hemodynamic significance of coronary stenosis, the overall diagnostic accuracy, sensitivity, specificity, positive predictive value, negative predictive value, positive likelihood ratio, and negative likelihood ratio of UFR were 92%, 91%, 96%, 96%, 91%, 25.0, and 0.10, respectively.In assessing functionally significant coronary stenosis, UFR demonstrates significantly superior diagnostic performance compared to IVUS-based MLA, substantially enhancing the ability to diagnose functionally significant lesions.

To lower the operational threshold of IVUS and enable more physicians to interpret IVUS images, Pulse Medical has integrated AI into its platform. As an AI-based system for automated IVUS analysis and ultra-fast FFR calculation, AcoPilot can complete AI-driven, ultra-fast automated IVUS image analysis within 30 seconds. It provides morphological assessment of blood vessels in each frame along with corresponding FFR and MLA values, enabling unique 3D plaque reconstruction and quantification, thereby helping physicians devise more precise PCI strategies.

At the Functional IVUS Symposium, Academician Wang Jian’an of The Second Affiliated Hospital of Zhejiang University School of Medicine affirmed the current applications of AI. He stated that the application of intelligence in cardiovascular diseases will not be limited to diagnosis but may further demonstrate its value in morphology and physiology, thereby better guiding subsequent treatment processes.

Furthermore, Pulse Medical has independently developed the UltraFlyer single-use intravascular ultrasound diagnostic catheter, with its fully domestically produced ultrasound transducer breaking the monopoly held by multinational corporations over this consumable.

The catheter features innovative designs, including a smoothed tip and a detachable structure, offering deliverability comparable to international competitors while ensuring high-quality imaging. According to physicians on site, the imaging quality of UltraFlyer has reached the level of industry leaders and fully meets clinical requirements. Without prior knowledge of the consumable’s manufacturer, it is difficult for them to distinguish between brands based solely on image differences.

Overall, Pulse Medical has demonstrated the value of AcoPilot through clinical practice, making one-stop multimodal structural and functional IVUS imaging a reality.

Relevant studies predict that the market size for coronary intravascular ultrasound (IVUS) in China is expected to reach RMB 6.43 billion by 2030. Pulse Medical Imaging Technology clearly has the opportunity to leverage its technological advantages to overtake competitors and capture market share from multinational medical device companies such as Boston Scientific and Philips.

However, Pulse Medical’s ultimate goal extends beyond this.

To date, Pulse Medical Imaging Technology has secured innovative medical device approvals from the National Medical Products Administration (NMPA) for its angiography-based QFR and coronary CTA-based CT-QFR products, among other innovative medical devices. Furthermore, the company has achieved full in-house research and development of complementary products, including equipment, consumables, and AI solutions, to support its extensive product portfolio.

In his address at the thematic session of the recently concluded OCC-WCC 2024, Academician Ge Junbo from Zhongshan Hospital Affiliated to Fudan University affirmed that Pulse Medical Imaging Technology (Shanghai) Co., Ltd. has made numerous innovations in the cardiovascular field. He stated, “Domestic startups should not merely focus on redeveloping already marketed consumables and engaging in cutthroat competition within mature sectors. Instead, they should prioritize original innovation and explore new markets, thereby sustaining long-term vitality in the cardiovascular sector.”

Therefore, Pulse Medical will continue to prioritize original innovation, further developing a comprehensive product portfolio that covers the entire workflow of precise vascular diagnosis. By establishing a true closed-loop system for precision diagnosis and treatment in coronary intervention, the company aims to drive the inclusion of its solutions into clinical guidelines and standards for percutaneous coronary intervention. In doing so, Pulse Medical seeks to build robust product and commercial barriers in the niche sector of pan-vascular precision diagnosis, while providing patients with coronary artery disease with superior diagnostic and therapeutic options.