Beixin's Coronary Pressure Microcatheter Gains Approval in China

Wireless freedom, precise breakthrough: Beixin coronary artery full-function pressure measurement microcatheter approved in China
2025-07-04 15:53·Sina Finance
Source: Zhonghong Network Official Micro
In the field of cardiovascular disease, 70% of coronary heart disease patients face a hidden crisis-non-obstructive ischemia (INOCA), of which 41% of patients face microcirculation disorders, which has become an invisible battlefield for the precise diagnosis and treatment of coronary heart disease. Clinical surgeons need to measure the level of coronary microcirculation resistance to clarify the cause of microcirculatory ischemia before surgery and evaluate the prognosis risk and surgical effect after surgery. However, the existing technology is either complex to measure, or the measurement repeatability and stability are insufficient, and more stable and efficient innovative solutions are urgently needed.

On June 27, 2025, the new generation of TruePhysio X wireless pressure microcatheter independently developed by Shenzhen Beixin Life Science Co., Ltd. (hereinafter referred to as "Beixin") was officially approved by the National Medical Products Administration (NMPA) for Class III medical device registration. As the first domestic integrated coronary functional evaluation solution, it not only has coronary epicardial vascular function evaluation indicators (FFR/cRR), but also realizes more stable and reliable coronary microcirculation resistance index (iMR) measurement through innovative multi-sensor adaptive dual-point flow velocity fusion technology, providing a "navigation-level" tool for accurate diagnosis and treatment of coronary heart disease.

Four major innovative breakthroughs: redefining functional measurement standards

Innovative breakthrough 1: wireless design

Wireless free control, abandoning long cables, free, simple, flexible, no obstacles during surgery, while reducing dependence on machine distance, bringing doctors a double upgrade of surgical fluency and surgical field of view.

Innovative breakthrough 2: Adaptive dual-point flow velocity fusion

Beixin pioneered multisensor-iMR (m-iMR) technology beyond imports, breaking through the limitations of traditional technology, realizing efficient and stable iMR measurement, with high repeatability and success rate, which can significantly improve operational efficiency.

Innovation Breakthrough 3: Intelligent Dynamic Compensation

With m-iMR dual temperature curve correction compensation technology, real-time correction of cardiac pulsation interference is achieved, and data fluctuation rate is reduced by 40%, ensuring accurate measurement results and numerical balance, providing clinical operators with reliable measurement results.

Innovation Breakthrough 4: Fast Exchange

It is compatible with any 0.014'' working guidewire, and can move freely on the guidewire track, breaking through multi-branch/bifurcation/diffuse tandem lesions, and is quick to use and friendly to novices.

Clinical performance: more stable measurement, 33% efficiency improvement

In animal experiments and clinical trials, Beixin m-iMR showed stability advantages: the number of injections of saline required for stable measurement results is 33% less than that of similar products, and the measurement stability is higher, which can save surgical time. Operators can operate completely independently after several trials.

Clinical guidelines and expert consensus: more and more attention is paid to microcirculation measurement

In the field of cardiovascular disease diagnosis and treatment, the evaluation of microcirculation function is receiving increasing attention. Domestic experts have reached a consensus based on a large amount of clinical practice and research data, and clearly pointed out that in the process of clinical diagnosis and treatment, it is necessary to measure the microcirculation of patients with cardiovascular diseases, which helps to more accurately identify the causes of microcirculatory ischemia, formulate surgical plans, and evaluate the prognosis.

At the international level, the "2024 European Society of Cardiology Guidelines for the Management of Chronic Coronary Syndromes" has raised the recommendation level of microcirculation measurement from IIa to I, which means that it strongly supports the application of this measure in clinical practice, thereby providing important decision-making basis for clinicians.

Solve the problem of microcirculation with domestic innovation

As the core component of Beixin's intelligent and precise PCI solution, TruePhysio X wireless pressure microcatheter provides a Chinese intelligent solution for the diagnosis and treatment of microcirculatory diseases with its four major technological innovations: wireless design, adaptive dual-point flow velocity fusion, intelligent dynamic compensation, and rapid exchange, and promotes the standardized development of precise diagnosis and treatment of coronary heart disease. Looking forward to the future, we expect this industry-leading intelligent and precise PCI innovative tool to be widely used in clinical practice, enter more catheter rooms, empower medical professionals, and help clinical improvement of the life and health of coronary heart disease patients around the world.