Heyuan Medical's NOVAtria® System – World’s First Low Retrograde Shunt, Integrated 'Therapy + Monitoring' Heart Failure Implant – Showcased at HFSA 2025

United InnoMed^®Submission for NOVAtria^®The results of two studies from the systematically conducted chronic animal trials ("Feasibility Of A Novel Implantable Device To Provide Heart Failure Therapy And Left Atrial Pressure Monitoring In A Chronic Animal Study" and "Evaluation Of A Novel Interatrial Shunting Device Capable Of Reducing Paradoxical Flow In Bench And Animal Studies") were both accepted by the conference, where they were orally presented to share and discuss the relevant research data and outcomes with experts from around the world. The findings of the two studies demonstrated the potential of NOVAtria.^®The safety and feasibility of the system, as well as its feasibility in reducing reverse shunting (from the right atrium to the left atrium).

United InnoMed^®Self-developedNOVAtria^®The system integrates atrial shunt therapy and left atrial pressure monitoring functions, and is currently the world's only atrial shunt device product with low reverse shunt functionality. This unique design can better meet clinical needs by effectively reducing reverse shunting, thereby further decreasing the risk of emboli from the right heart system entering the left heart system and enhancing system safety.NOVAtria^®The system's clinical value and significance have garnered attention and recognition from the attending experts, sparking in-depth discussions.

United InnoMed^®The three-month follow-up results of the chronic animal trial were announced at the European Society of Cardiology (ESC) Annual Congress and World Congress of Cardiology held in Spain at the end of August 2025. The longer six-month follow-up results and the feasibility of atrial shunt flow were disclosed at HFSA 2025.

1.In terms of safety, all animals survived to the expected follow-up points. The six-month follow-up results showed that NOVAtria^®The system shunt channel remained patent, with complete endothelialization, and no device-related adverse events were observed.

2.In terms of pressure measurement accuracy, the six-month follow-up point was passed.PowerLabRecordSwan-GanzMeasuredPCWPAnd recording the implant measurements via an external reader.LAPComparison of pressure waveforms, throughPearsonCorrelation Analysis andBland-AltmanFigure EvaluationPCWPAndLAPThe correlation and consistency between them. The results showed that after adding six months of follow-up data,PCWPAndLAPStill maintaining good correlation and consistency, the average difference at the six-month follow-up point is close to the three-month average difference, further verifying the long-term stable performance of pressure measurement accuracy.

3.In terms of atrial shunting,NOVAtria^®The system features a unique low reverse shunt design, which reduces the risk of emboli from the right heart system entering the left heart system by decreasing the right-to-left shunt flow to minimize reverse shunting. The research progress shared this time presents the validation results of the low reverse shunt design in both laboratory and animal studies. The results show that the reverse shunt performance in animals is consistent with laboratory validation and theoretical design, effectively reducing the risk.30%The above reverse shunt.

Research Summary and Outlook

This time inHFSAThe research data shared and published further validatesNOVAtria^®The system's safety, feasibility, and long-term accuracy in measuring left atrial pressure have been validated through longer-term follow-up data. Meanwhile, it provides support for subsequent registration clinical trials.NOVAtria^®The system is about to conduct a large-scale randomized controlled clinical trial before its market launch to verify the system's safety and effectiveness.

About NOVAtria^®System

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 type of "treatment.+An integrated solution for monitoring, which, through special structural design, ensures smooth left-to-right shunting while reducing the reverse flow from right to left. This reduces the risk of right-heart emboli entering the left-heart system, thereby 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 during rest and exercise. Multi-dimensional pressure data provide doctors with the necessary support and basis for understanding the patient’s heart failure status and evaluating the effectiveness of atrial shunt therapy, truly achieving "intraoperative pressure measurement."+Postoperative Evaluation+"Long-term monitoring" full-process heart failure management.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^®（United InnoMed^®) was established 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 present, the products under development 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 electrical stimulation circulatory assistance.

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 foreign invention patents. 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.