Boosting Precision in Coronary Artery Disease Diagnosis: Pulse Medical Imaging's QFR System Approved for Market Launch

VCBeat (WeChat ID: vcbeat) has learned that the Quantitative Flow Ratio (QFR) measurement system, independently developed by Pulse Medical Imaging, officially received market approval from the China National Medical Products Administration (NMPA) in July and held its clinical launch ceremony in Beijing on August 4. Compared with conventional coronary angiography currently used in clinical practice, QFR technology improves the accuracy of diagnosing myocardial ischemia by 33%. It offers rapid and convenient measurements that can be performed in real time during percutaneous coronary intervention (PCI). As a China-first innovation, the QFR measurement system is poised to become the new global standard for diagnosing coronary heart disease (CHD). It is expected to significantly reduce medical expenditures for CHD and improve patient outcomes, with related clinical studies currently underway worldwide.

At the launch meeting, clinical experts and scholars enthusiastically discussed the innovative path forged by QFR technology through its “government-industry-academia-research-application” model, hailing it as a paradigm for China’s vigorous promotion of independent innovation in medical devices. Characterized by high technological intensity, extensive interdisciplinary integration, and stringent regulatory oversight, the medical device sector has seen the emergence of a wave of innovative products, exemplified by QFR, against the backdrop of strong national support for interdisciplinary collaboration and the coordinated development of government, industry, academia, research, and healthcare institutions. Scientists’ R&D achievements have been rapidly translated into clinical practice through industrial commercialization and collaborative efforts with top-tier Chinese hospitals, including Fuwai Hospital of the Chinese Academy of Medical Sciences and the Chinese PLA General Hospital, thereby enabling the clinical application of QFR technology to benefit patients.

Meanwhile, the state has played a significant role in promoting QFR technology through its medical device registration and review processes. The collaborative efforts of top-tier Chinese hospitals, such as Fuwai Hospital of the Chinese Academy of Medical Sciences and the Chinese PLA General Hospital, have facilitated the rapid clinical translation and application of QFR technology, thereby benefiting patients. Furthermore, the National Medical Products Administration’s “Innovative Medical Device” special approval pathway has accelerated the regulatory approval process for QFR.

QFR, the Quantitative Flow Ratio measurement system, is an innovative medical device independently developed by Pulse Medical Imaging. By performing intelligent post-processing calculations on X-ray coronary angiography images, it generates a value known as “QFR” that reflects the severity of myocardial ischemia, thereby assisting physicians in making precise diagnoses for patients with coronary artery disease. This facilitates the determination of whether stent implantation is required and aids in planning the stenting procedure.

PulseQFR was granted special approval for innovative medical devices by the China Food and Drug Administration (CFDA) in May 2017, and received CFDA Class III medical device registration certification in July 2018, becoming the world’s first wire-free FFR technology approved by the CFDA; QFR obtained CE certification in 2017.

Coronary heart disease (CHD) is a condition characterized by myocardial ischemia resulting from reduced blood supply to the heart muscle, caused by coronary artery narrowing due to the accumulation of atherosclerotic plaques. Physicians obtain coronary images through minimally invasive X-ray coronary angiography to diagnose the severity of coronary stenosis. If stent implantation is deemed necessary, percutaneous coronary intervention (PCI) is commonly performed to implant a stent in the affected lesion, a procedure colloquially known as “stenting.” In China, there are up to 13 million patients with CHD; in the past year alone, 753,000 individuals underwent PCI, and approximately more than 3 million people received coronary angiography examinations.

At the clinical application launch conference, Professor Xu Bo, Director of the Interventional Catheterization Laboratory at Fuwai Hospital, Chinese Academy of Medical Sciences, stated that a recent authoritative European clinical study found a misdiagnosis rate as high as two-thirds when diagnosis relies solely on visual assessment of stenosis severity by physicians. Specifically, in 28% of coronary artery lesions, imaging suggests severe stenosis, but no myocardial ischemia is present; in such cases, stent implantation does more harm than good. Conversely, in 13% of coronary artery lesions, imaging indicates non-severe stenosis, yet myocardial ischemia has actually occurred, necessitating stent implantation. Therefore, rapid, effective, precise, and cost-effective functional diagnostic tools for coronary heart disease have become both a focal point and a significant challenge in the current cardiovascular field.

At the launch ceremony, Professor Xu Bo, Director of the Cardiac Catheterization Laboratory at Fuwai Hospital, Chinese Academy of Medical Sciences, stated, “2018 is the Year of Coronary Physiology. Physiology-guided percutaneous coronary intervention (PCI) yields significant long-term prognostic benefits for patients.” Functional assessment of coronary physiology offers substantial health economic benefits in the diagnosis and treatment of coronary artery disease (CAD), reducing medical expenditures by 15% while improving patient outcomes. Currently, the gold standard for functional assessment of coronary physiology is fractional flow reserve (FFR). This technique involves advancing a pressure guidewire via the radial artery to the distal segment of the coronary lesion. During maximal hyperemia induced by adenosine or ATP administration, the distal lesion pressure (Pd) and aortic pressure (Pa) are measured to calculate FFR as Pd/Pa.

However, the global adoption of FFR measurement is limited due to several drawbacks: the high cost of disposable pressure wires (exceeding RMB 10,000), the complexity and time-consuming nature of the procedure, side effects associated with adenosine/ATP administration, risks of plaque rupture inherent to its invasive nature, and inability to measure severely tortuous lesions. In China, in particular, the application rate is approximately 1%, meaning that 99% of patients with coronary heart disease do not receive optimal diagnostic assessment and may consequently miss out on the best treatment plans, leading to a waste of medical resources. Currently, FFR technology is monopolized by foreign companies such as Abbott (which acquired St. Jude Medical) and Philips (which acquired Volcano Corporation).

In recent years, image-based wire-free fractional flow reserve (FFR) technology has become a hot topic. Its advantage lies in obtaining FFR values without using any consumables or performing additional surgical procedures. In 2014, the U.S. company HeartFlow received FDA approval for a technology called FFR-CT, which calculates FFR values based on coronary computed tomography angiography (CCTA) images. This technology has now entered clinical application in Europe, the United States, Japan, and other countries. In February of this year, HeartFlow completed its Series E financing round, raising $240 million and achieving a post-money valuation of $1.5 billion. However, studies have shown that the current diagnostic accuracy of FFR-CT is only equivalent to that of X-ray-based coronary angiography with visual assessment by physicians. Moreover, FFR-CT requires a lengthy time to reconstruct the coronary arterial tree, and it has lower diagnostic accuracy for complex lesions, particularly calcified lesions. Currently, this technology can only be used in the early screening stage.

X-ray coronary angiography is an essential tool for diagnosing coronary heart disease. The successful development and market launch of Pulse Medical Imaging’s QFR technology, based on “coronary angiography image analysis,” has sparked widespread discussion within the industry. The first-generation QFR technology, completed in 2014, relies on coronary angiography performed under conditions of induced maximal hyperemia. It utilizes angiographic image sequences acquired from two projection angles greater than 25 degrees apart for three-dimensional reconstruction, and combines this with the TIMI frame count method to obtain individualized blood flow velocity for QFR calculation. This approach eliminates the need for pressure guidewires, requires no more than ten minutes for computation, and demonstrates a significant correlation with FFR values measured by pressure guidewires.

To further optimize workflows and minimize patient impact, the Pulsar team completed the development of the second-generation QFR technology in 2016. This technology enables rapid online assessment of FFR (with the entire evaluation taking approximately 1 to 2 minutes), eliminates the need for vasodilator drugs such as adenosine, and allows QFR assessment using routine coronary angiography. In November 2017, Professor Xu Bo from Fuwai Hospital, Chinese Academy of Medical Sciences, on behalf of the FAVOR II China study team, presented the latest research findings at the main session of the 2017 TCT conference in Denver, USA. The results demonstrated that QFR achieved a high concordance rate of 92.7% with the gold standard FFR in diagnosing functional coronary stenosis, representing a 33% improvement in accuracy compared to current conventional diagnostic techniques primarily based on visual interpretation of coronary angiography images.

Professor Patrick W. Serruys of the Imperial College London International Centre for Circulatory Health emphasized at this year’s EuroPCR conference, “The clinical application of QFR will trigger a tsunami in the medical community focused on coronary artery disease.” Professor Alexandra Lansky, Director of the Cardiovascular Research Center at Yale University, also stated at the 2017 TCT conference, “QFR technology is expected to become routinely used in every interventional catheterization laboratory in the future.” Currently, QFR has been implemented in clinical practice at dozens of hospitals worldwide and is recommended for use in Japanese expert consensus guidelines. The clinical adoption of QFR is poised to become the “new standard” for future functional assessment of coronary physiology, enhancing diagnostic accuracy for coronary artery disease, improving patient outcomes, and delivering substantial health economic benefits.

The co-founders of Bodong Medical Imaging are Ms. Liu Bing, CEO, and Professor Tu Shengxian, Chief Scientist. Ms. Liu graduated from Shanghai Jiao Tong University and possesses extensive experience in cardiovascular marketing, sales, and management, having previously held marketing and management positions at Medtronic. Professor Tu Shengxian, the inventor of QFR technology, is a “Young Changjiang Scholar” appointed by the Ministry of Education, a Distinguished Professor under the Oriental Scholar Program, a Professor at Shanghai Jiao Tong University, an Associate Professor at Leiden University in the Netherlands, a Fellow of the American College of Cardiology (FACC), and a Fellow of the European Society of Cardiology (FESC).

The company boasts a robust and well-established management and operations team, with its core members hailing from medical industry giants such as GE Healthcare, Medtronic, Cisco, and Siemens Healthineers. Its R&D team comprises senior scientists and engineers from leading medical corporations as well as prestigious universities, including Shanghai Jiao Tong University, the University of Pennsylvania, Leiden University, and Huazhong University of Science and Technology. Furthermore, Pulmovision Medical Imaging maintains a joint R&D laboratory with Shanghai Jiao Tong University, fostering sustained innovative capacity for the team.

Pulsar Medical Imaging, with clinical practice as its starting point, promptly returns to clinical validation and application upon achieving technological innovation. The company has established in-depth clinical and research collaborations with dozens of leading hospitals both domestically and internationally, including Fuwai Hospital of the Chinese Academy of Medical Sciences, the 301 Hospital (PLA General Hospital), Yale Medicine Center, and Aarhus University’s Department of Clinical Medicine in Denmark. It is committed to the independent development of precise cardiovascular diagnostic technologies, thereby contributing to cardiovascular health.