ArteryPlanner Secures NMPA Class III Approval as World’s First Standalone Cardiovascular Surgical Planning Software, Transforming PCI into a Predictable Precision Science

Recently, independently developed by Hangzhou Atrui Technology Co., Ltd.ArteryPlanner(Generic name: Aterui Cardiovascular Surgical Planning Software) has officially received approval from the National Medical Products Administration (NMPA) Class III Medical Device Registration Certificate (National Medical Device Registration Approval No.20263210719）。

As the world’s first cardiovascular surgical planning system approved as standalone software,ArteryPlannerThe market launch marks a historic leap for China in the field of cardiovascular precision medicine, transitioning from “following” to “leading,” and will percutaneous coronary intervention (PCI) has formally advanced from an experience-dependent “craft” into a computable and predictable “precision science.”

This product is based on patients' routine coronary arteriesCTAData, Automatically Generated1:13D coronary artery tree model, supporting preoperative virtual stent implantation simulation and postoperative outputFFRPredicted Value (FFRplan), enabling surgeons to “foresee” surgical outcomes before the procedure and completely eliminate the risks associated with “blind” surgeries.

Self1977Since the first percutaneous coronary angioplasty case of the year was performed,PCIPercutaneous coronary intervention has become the mainstream treatment for coronary artery disease. However, over the past half-century, clinicians have continued to face significant challenges: how to accurately assess lesions, how to select the most appropriate stent, and how to ensure optimal post-procedural outcomes.

Clinical statistics show that traditionalPCIIntraoperative, Gao Da50%of patients postoperative fractional flow reserve (FFR) failed to achieve0.90ideal standards, with more24%of patientsFFRDeficiencies0.80. This means that for some patients, the problem of myocardial ischemia is not fundamentally resolved after enduring surgical trauma and financial burden.

TraditionalPCISurgical procedures are heavily reliant on physicians' individual experience and two-dimensional angiographic images, leading to pain points such as inaccurate lesion assessment, difficulties in matching stent size and position, and uncontrollable postoperative outcomes. This is particularly evident in complex bifurcation lesions and diffuse lesions, where young physicians face an extremely steep learning curve.

ArteryPlannerIt was developed precisely to address this clinical challenge. Physicians can freely adjust the size, number, and placement of virtual stents via the software, and the system will calculate and output postoperative outcomes for various scenarios.FFRPredicted values. Through comparative analysis of multiple options, physicians can tailor the optimal surgical strategy for each patient, ensuring postoperativeFFR≥0.90the gold standard of evidence-based medicine.

In the global field of cardiovascular imaging and physiological assessment, the United States’HeartFlowThe company had long held a leading position, it was reported,HeartFlowThe company expects2026Year6similar products can be launched after a month (PCIsurgical planning software). However,ArteryPlannerNot only does it fully benchmark against competitors in terms of functionality, but it also surpasses them in product form and underlying algorithms. It is the world’s first to be officially approved as standalone softwareNMPAAs an approved Class III medical device, its standalone software form grants hospitals significant deployment flexibility and data security, unlike traditional systems that must be tied to specific hardware devices or restricted to particular cloud platforms, truly realizing the principle of “letting technology adapt to hospitals, rather than forcing hospitals to accommodate technology.”

In terms of core underlying technologies,ArteryPlannerEquipped with the renowned computational fluid dynamics algorithm proposed by the company’s founder—N-K-S. Hemodynamic simulation within the cardiovascular system involves extremely complex Navier--The Navier-Stokes equations are widely recognized as one of the seven Millennium Prize Problems in mathematics.

Under the leadership of its founder, the R&D team at Atrui Technology has achieved a breakthrough byN-K-SThe algorithm is applied to high-precision fractional flow reserve (FFR) calculation. It not only fully accounts for the elastic deformation of vessel walls but also achieves world-leading performance in both computational speed and accuracy. Previously, this algorithm underwent large-scale parallel computing validation on China’s “Tianhe-2” supercomputer, demonstrating unparalleled computational power and robustness.

ArteryPlannerclinical application, which is not only an upgrade of technical tools but also a value reshaping of the entire cardiovascular medical ecosystem. Clinical studies have shown that after using this planning software, nearly50%The shift in the patient’s treatment strategy has directly yielded a “four-way win” for patients, physicians, hospitals, and public health insurance.

For patients, precision medicine delivers lifelong benefits. It avoids unnecessary stent implantation, reduces surgical trauma and complications, and ensures effective improvement of postoperative myocardial ischemia (FFR≥0.9), improve long-term quality of life; reduce overall healthcare costs.

For Physicians: Smart Empowerment, Accelerating the Learning Curve. Preoperative simulation eliminates surgical blind spots and boosts confidence in managing complex lesions; significantly shortens the learning curve for young physicians; provides objective data support to optimize doctor-patient communication and reduce medical disputes.

Hospital Side: Quality Improvement, Efficiency Enhancement, and Discipline Construction. Improve the operational efficiency of the catheterization laboratory and reduce the duration of individual procedures; enhance the overall diagnostic and therapeutic capabilities of the Department of Cardiology, and establish a regional center for precision cardiovascular diagnosis and treatment; comply withDRG/DIPPayment Reform Orientation.

Social Health Insurance: Cost Control, Reduction, and Resource Optimization. Reduce unnecessary stent consumption, lower readmission and reoperation rates; allocate health insurance funds where they matter most to achieve efficient and rational distribution of medical resources.

Atrui Technology’s breakthrough was no accident; it is underpinned by an internationally top-tier research and development team. Led by a renowned computational mathematician, the company brings together interdisciplinary elites from leading research institutions. This deep integration of “industry, academia, research, and clinical practice” enables Atrui Technology to closely align cutting-edge mathematical algorithms and high-performance computing technologies with critical pain points in clinical medicine.ArteryPlannerThe successful approval is a testament to the fruits of this model.

The General Manager of Hangzhou Aterui Technology Co., Ltd. stated, “ArteryPlannerApprovedNMPAThe Class III certification is merely the starting point for us to fulfill our mission of “focusing on precision cardiovascular medicine and empowering every cardiologist.” In the future, we will continue to deepen our expertise in computational medicine, driving the clinical implementation of more cutting-edge algorithms, so that everyPCI“All surgical procedures are evidence-based, ensuring that every cardiovascular patient receives precise, safe, and efficient medical care.”