Recently, RainMed Medical Coronary Function Measurement System (hereinafter referred to as "RainMed caIMR") has successfully entered the special approval channel for innovative medical devices of NMPA, and has obtained the priority of NMPA certification. As the world's leading non-interventional microcirculation diagnosis system, the approval of caIMR fully reflects the international leadership of its technology and its superior clinical value.

The approval of the innovative application of caIMR will accelerate its commercialization, accelerate the opening of tens of billions of blue ocean market for microcirculation diagnosis, and lead the cardiovascular field into a new era of comprehensive assessment of myocardial functional ischemia. It also lays a key foundation for RainMed Medical to build a vascular interventional surgery robot covering the whole process of comprehensive diagnosis and treatment.

Announcement of the review results of the special application for innovative medical devices

As a green channel for medical device approval, the special approval channel for innovative medical devices has a high approval threshold and a very low approval rate. Since the implementation of the approval process in 2014, only 170 products have been approved in China and the approval rate is only 20%. Among them, the caIMR and caFFR of RainMed and their supporting supplies have been successfully approved to enter the green channel of innovative medical devices, demonstrating RainMed Medical's excellent innovative R&D capabilities.

Preferential policy support and excellent clinical results jointly help RainMed to accelerate the commercialization of caIMR

In the process of coronary heart disease diagnosis and treatment, IMR evaluation has important clinical significance and has been widely recommended by domestic and foreign guidelines. Data show that 40% of patients with coronary artery disease still suffer from recurrent angina after PCI, partly due to microcirculatory dysfunction. Therefore, guidelines such as "Guidelines for Diagnosis and Management of Chronic Coronary Syndrome", "Chinese Expert Consensus on Diagnosis and Treatment of Coronary Microvascular Diseases (2017)", "Chinese Multidisciplinary Expert Consensus on Diagnosis and Treatment of Microvascular Diseases (2020)" and other guidelines all recommend IMR assessment in patients with coronary heart disease.

caIMR of RainMed

caIMR of RainMed has made up for the deficiencies of traditional guide wire-derived IMR detection, and offered more practical clinical detection methods to coronary microcirculation. In the past, guide wire-derived IMR measurement requires the use of hyperemic agents and repeated injection of normal saline, which takes a long time to measure IMR and has a high risk and therefore it is only suitable for clinical research. caIMR does not require the pressure guide wire and hyperemic agents. It does not need to change the surgeon's surgical habits. It only takes an average of 5 minutes to measure IMR based on angiograms, blood flow velocity by TIMI frame count, real-time aortic pressure and a specially-designed CFD model. It is safe, efficient and simple, and offers a new opportunity to promote the large-scale clinical application of coronary microcirculation assessment.

As the world's first diagnostic method for coronary microcirculation function in the confirmatory clinical trial stage, RainMed caIMR was successfully approved to enter the green channel of innovative medical devices, bringing sufficient confidence to accelerate the large-scale clinical application of the product.

As of December 2021, RainMed caIMR has successfully completed the clinical enrollment of the confirmatory trial. The study is led by Zhongshan Hospital Affiliated to Fudan University with the top cardiology experts academician Ge Junbo and Professor Huo Yong of Peking University First Hospital as PI. At present, caIMR has achieved excellent clinical research results and has successfully entered the registration clinical stage.

caIMR confirmatory clinical research launch ceremony

The preferential policies and assistance to high-innovation medical devices given by the state and the confirmatory clinical results that exceeded expectations have brought more confidence to accelerate the commercialization of caIMR. It is believed that the large-scale clinical application of caIMR will surely improve the level of diagnosis and treatment of coronary artery disease and lead coronary artery disease into a new era of precision medicine. 

Top SCI journals confirm that caIMR of RainMed has a wide range of clinical indications and excellent clinical application value

The global initiative of RainMed caIMR has attracted extensive attention from well-known experts at home and abroad, and has become a hot topic of international clinical research. A number of blockbuster research papers published in SCI journals have made detailed demonstrations on the wide range of clinical indications and excellent clinical performance of caIMR.

Articles on caIMR have been published in SCI journals at home and abroad

Research shows that RainMed caIMR has a high consistency with guide wire-derived IMR, and can accurately assess microcirculation dysfunction in patients with stable angina, unstable angina and non-obstructive coronary heart disease (INOCA), revealing that caIMR can replace guidewire-derived IMR for functional diagnosis of patients with ischemic heart disease.

For patients with coronary non-obstructive myocardial infarction (MINOCA), caIMR can objectively perform risk stratification, independently predict the risk of adverse cardiovascular events, and assist patients in effective treatment and follow-up management. Therefore, experts recommend that caIMR measurement should be performed for patients with MINOCA.

For patients with ST-segment elevation myocardial infarction (STEMI), RainMed caIMR can accurately assess the patient's postoperative status and determine whether the patient has microcirculation obstruction. Compared with cardiac MRI technology, caIMR has better clinical applicability. It can accurately measure microvascular resistance in real time and evaluate microvascular dysfunction after surgery. 

It is worth mentioning that the team of Dr. Joo Myung Lee from Samsung Medical Center of Sungkyunkwan University in South Korea has conducted in-depth research on the role of RainMed caIMR in the diagnosis of STEMI patients after PCI for many times. One of the research articles has been published by the top journal "JACC". : Included in Cardiovascular Interventions. As an evidence-based clinical study with the highest impact and the most complete evidence chain in the field of IMR so far, this article has aroused extensive attention and discussion in the academic community.

caIMR of RainMed is highly recognized and eagerly anticipated by top experts and scholars at home and abroad

The excellent academic achievements and clinical performance of RainMed caIMR have been highly praised by experts and scholars around the world. Experts and scholars at home and abroad have been eagerly looking forward to this upcoming worldwide first functional measurement product.

Well-known foreign experts write comments for RainMed caIMR in JACC sub-journal

The world-renowned cardiovascular experts, George Stouffer, director of the Department of Cardiology at the University of North Carolina and director of the McAllister Heart Institute, and Joseph Rossi, a clinical professor of cardiology at the University of North Carolina, wrote a review for RainMed caIMR on "JACC: Cardiovascular Interventions". They praised caIMR as an exciting advancement, pointing out that the simple way of functional vascular measurement will provide better prognostic assessment for STEMI patients, facilitate the development of microvascular function diagnosis and treatment, and pave the way for later clinical trials and large-scale applications.

In China, Professor Huo Yong of Peking University First Hospital believes that RainMed caIMR provides a new opportunity for the development of precision medicine, which will maximize the prognosis of patients and promote the development of coronary function. Professor Chen Yundai from Chinese PLA General Hospital said that she attaches great importance to the application prospects of RainMed caIMR technology. caIMR aims at the problems related to the diagnosis of microcirculation. With the limited measurement methods in the current situation, RainMed caIMR has great potential. Professor Xu Bo of Fuwai Hospital, Chinese Academy of Medical Sciences highly recognized the scientific research capabilities of RainMed Medical. He pointed out that the clinical application of RainMed caIMR will greatly improve the diagnosis and treatment of coronary heart disease caused by microcirculation. In the future, caIMR will have huge application prospects.

The marketization of RainMed caIMR will lead the cardiovascular field into a new era of comprehensive assessment of myocardial ischemia. At the same time, as the core product and an important part of the robot's digital functional module, the R&D and launch of RainMed caIMR will accelerate the implementation of the strategy of vascular interventional surgery robots covering the whole process of diagnosis and treatment, build an unmanned operating room, and help solve the problem of different medical levels, uneven distribution of doctors and patients, etc., to better empower clinical operators and benefit the majority of patients.

Vascular Intervention Robot of RainMed