Heyuan Medical's NOVAtria® System Debuts at ESC 2025, Pioneering Integrated 'Therapy + Monitoring' Solution for Heart Failure Management

From August 29 to September 1, 2025 local time, the European Society of Cardiology Congress 2025 (ESC 2025) and the World Congress of Cardiology were held in Madrid, Spain, under intense global attention. With 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 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 measurements of the device, demonstrating the potential of NOVAtria.^®System security and feasibility.

United InnoMed^®Self-developed NOVAtria^®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 received widespread attention from experts at the conference from various countries.

Currently, heart failure implant devices on the market 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 product. —— United InnoMed^®Self-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 were evaluated in a chronic animal model by comparing the left atrial pressure (LAP) measured by the system with the pulmonary capillary wedge pressure (PCWP) measured by Swan-Ganz.

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 implanted into 10 healthy dogs, with 4 followed up for one month and 6 followed up for three months. 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.

The results of this study showed that all devices were successfully implanted, and the shunt channels of the devices remained unobstructed at 1 month and 3 months post-implantation. No device-related adverse events were observed, and the devices were well endothelialized within 3 months after implantation.

According to Pearson correlation analysis, LAP and PCWP showed a good correlation, with an R² of 0.87 and a mean difference of 0.33 ± 1.8 mmHg. Bland-Altman correlation analysis demonstrated that the majority fell within the 95% limits of agreement, indicating good consistency between LAP and PCWP.

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

NOVAtria^®The system is from 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 lowering 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. At the same time, 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 effectiveness of medical devices, provide global doctors with superior heart failure management tools, and bring better clinical benefits to heart failure patients.

United InnoMed^®Founder and CEO Dr. Wang LiIn recent years, significant progress has been made globally in the device treatment of heart failure. However, many clinical needs remain unmet, especially in the treatment and long-term management of patients with chronic heart failure. United InnoMed^®Focused on the development of innovative Class III active implantable products in the field of heart failure, NOVAtria^®As our first self-developed product entering the clinical trial stage, the system 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 multidimensional data, providing key scientific evidence for the clinical trial protocol. We are also greatly honored to see that related research findings have been accepted by the ESC Congress, gaining attention and recognition from experts worldwide. With the joint support of experts, we look forward to NOVAtria.^®The system can verify its safety and effectiveness in clinical settings as soon as possible, benefiting a large number of heart failure patients.

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: ① For chronic heart failure patients, long-term implantable products that integrate "treatment + diagnosis"; ② For acute heart failure inpatients, short-term electrical circulatory support (Electrical Circulatory Support) devices.

All of the company's products under development are independently researched and developed, and are global firsts. The company has applied for more than a hundred domestic and international invention patents. Since its establishment, the company has been committed to creating a truly comprehensive closed-loop management ecosystem for both acute and chronic heart failure that integrates "treatment + assessment + chronic disease management." It has also built multiple globally leading and highly collaborative technology platforms. Through thorough research and validation, the company aims to promote its products to serve heart failure patients in China and around the world.