Heyuan Medical's NOVAtria® System Showcased at ESC 2025: A First-in-Class Integrated Solution for Heart Failure Therapy and Monitoring

From August 29 to September 1, 2025 local time, the 2025 European Society of Cardiology Congress (ESC 2025) and the World Congress of Cardiology will be held in Madrid, Spain, drawing global attention. Under the theme of "Global Health," this year’s conference focuses on "Cardiology Beyond Borders." By emphasizing innovative therapies and cutting-edge products, the event delves into the evolving role of cardiovascular diseases within the global health landscape.

United InnoMed^®For NOVAtria^®The results of the systematically conducted chronic animal trial study (Feasibility of a novel implantable device to provide heart failure therapy and left atrial pressure monitoring in a chronic animal study) were successfully accepted by the conference, where they were presented and shared on-site. The study validated the 1-3 month shunt patency and accuracy of left atrial pressure measurement of the device, demonstrating the potential of NOVAtria.^®The safety and feasibility of the system.

United InnoMed^®Self-developedNOVAtria^®The system integrates atrial shunt therapy and left atrial pressure monitoring functions, which has significant clinical implications for the management of chronic heart failure and has garnered widespread attention from experts at the conference.

One surgery can achieve the full-process heart failure management of "heart failure treatment + postoperative therapy evaluation + long-term chronic disease management."

Currently available heart failure implantable devices can only provide either therapeutic or monitoring functions, such as atrial shunt devices and pulmonary artery pressure monitoring systems, but are unable to achieve both functions in a single device. —— United InnoMed^®Independently Developed NOVAtria^®The system integrates atrial shunt therapy and left atrial pressure monitoring functions, achieving "heart failure treatment + postoperative therapy evaluation + long-term chronic disease management" for patients through a single surgery. This study aims to evaluate NOVAtria.^®The system's feasibility and its pressure measurement accuracy, as assessed by comparing left atrial pressure (LAP) measured by the system with pulmonary capillary wedge pressure (PCWP) measured by Swan-Ganz in chronic animal models.

NOVAtria^®The system consists of an implant, a delivery system, and an external reader. The implant itself has no battery, and the external reader works with the implant to directly measure left atrial pressure in a wireless and non-invasive manner. The implant is fixed on the atrial septum for atrial shunting and left atrial pressure measurement. In this study, the implants were respectively placed into 10 healthy dogs, with a follow-up period of one month for 4 dogs and three months for 6 dogs. Gross anatomical examination and pathological examination were performed at the terminal follow-up. The PCWP measured by Swan-Ganz was recorded via PowerLab, and the LAP pressure waveform measured by the implant was recorded via the external reader. Pearson correlation analysis and Bland-Altman plots were used to evaluate the correlation and agreement between LAP and PCWP.

Smooth shunt, good endothelialization, NOVAtria^®The system is about to launch a large-scale randomized controlled clinical trial.

This study's results show that all devices were successfully implanted, and the shunt channels remained unobstructed at 1 month and 3 months post-implantation. No device-related adverse events were observed, and the devices showed good endothelialization within 3 months after implantation.

According toPearsonCorrelation Analysis,LAPAndPCWPThe correlation is good,R²For0.87, with an average difference of0.33±1.8mmHg。Bland-AltmanCorrelation analysis shows that the vast majority fall within95%Within the limits of consistency, indicatingLAPAndPCWPThere is good consistency between them.

This study preliminarily validated NOVAtria^®The system's feasibility, as well as the accuracy of measuring left atrial pressure, was validated through comparison with PCWP. Additionally, sufficient supportive information was provided for subsequent registration clinical trials. NOVAtria^®The system is about to conduct a large-scale randomized controlled clinical trial to verify its safety and effectiveness.

With multiple globally pioneering innovative designs and core technologies,

Aiming to Bring Better Clinical Benefits to Heart Failure Patients

NOVAtria^®The system is provided by United InnoMed^®Independently developed, integrating two main functions: atrial shunt therapy and left atrial pressure monitoring. This system aims to provide heart failure patients with a new "treatment + monitoring" integrated solution. Through a special structural design, it ensures the smooth left-to-right shunt while reducing the reverse right-to-left shunt flow, thereby decreasing the risk of right-heart emboli entering the left-heart system and enhancing the safety of atrial shunting.

NOVAtria^®The delivery system can support intraoperative catheter pressure measurement to obtain baseline values of the patient's left and right atrial pressures. Meanwhile, the system allows for long-term, non-invasive home monitoring of left atrial pressure at rest and during exercise. Multi-dimensional pressure data provide doctors with support and evidence to understand the patient’s heart failure status and evaluate the effectiveness of atrial shunt treatment, truly achieving comprehensive heart failure management through "intraoperative pressure measurement + postoperative evaluation + long-term monitoring."

NOVAtria^®The system boasts multiple globally pioneering innovative designs and core technologies, aiming to address unmet clinical needs, enhance the safety and efficacy of medical devices, provide global doctors with superior heart failure management tools, and bring better clinical benefits to heart failure patients.

United InnoMed^®Founder andCEODr. Wang Li:In recent years, device-based treatments for heart failure have made significant progress globally, but many clinical needs remain unmet, especially in the treatment and long-term management of patients with chronic heart failure. United InnoMed^®Focus on the development of innovative Class III active implantable products in the field of heart failure.NOVAtria^®The system, as our first self-developed product about to enter the clinical trial phase, integrates innovative concepts in heart failure treatment and several globally pioneering technologies. Long-term animal testing is a crucial part of the R&D process. The United InnoMed team not only validated core functionalities through rigorous scientific models but also systematically collected multi-dimensional data, providing key scientific evidence for the clinical trial protocol. We are also very honored to see that related research findings have beenESCThe conference received attention and recognition from experts around the world. We look forward to the joint support of the experts.NOVAtria^®The system can verify its safety and effectiveness in clinical settings as soon as possible, benefiting a large number of heart failure patients.

About United InnoMed

United InnoMed^®（United InnoMed^®) was founded in 2020, focusing on the development of innovative Class III active implantable products, and is committed to providing cost-effective "closed-loop" heart failure management solutions for heart failure patients worldwide. At this stage, the products under research cover the management of both acute and chronic heart failure patients, mainly including: ①For chronic heart failure patients, long-term implantable products that integrate "treatment + diagnosis"; ②For acute heart failure inpatients, short-term Electrical Circulatory Support (ECS) used for circulatory assistance.

All products under development by the company are independently researched and globally pioneering, with over a hundred domestic and international invention patents applied for cumulatively. Since its establishment, the company has been committed to creating a truly effective treatment for heart failure.+Evaluation+The "Chronic Disease Management" acute and chronic heart failure closed-loop management ecosystem, and the establishment of a globally leading, highly collaborative multi-technology platform. Through thorough research and validation, promote product services for heart failure patients in China and globally.