SHINEYO Medical Showcases RhythPulse®-PFA Pulsed Field Ablation System at OCC 2026 with Strong Clinical Validation and Product Innovation

The conference has invited Shanghai General Hospital, affiliated with Shanghai Jiao Tong University School of Medicine.Professor Liu ShaowenZhongshan Hospital, Fudan UniversityProfessor Nie ZhenningCo-hosted the event as co-moderators.

In their opening remarks for this sharing session, the two professors pointed out that China has over 20 million patients with atrial fibrillation. Although traditional ablation demonstrates significant efficacy, it still faces challenges such as procedural complexity, a steep learning curve, and the risk of complications. Leveraging its tissue-selective ablation mechanism, Pulsed Field Ablation (PFA) technology enables precise myocardial ablation within milliseconds while sparing the esophagus, blood vessels, and nerves, thereby truly realizing the clinical pursuit of “green electrophysiology.”

ShineyoMedical, as an innovation pioneer in the field of electrophysiology in China, its independently developedRhythPulse® Pulsed Field Ablation System, it is the first PFA system approved in China that integrates multi-channel, large-field, and targeted ablation, and this system has been selected by Shanghai"New Excellent Drugs and Medical Devices" Catalog and Pudong New Area Recommended Catalog of Innovative Drug and Medical Device Products, and completed the first batch of clinical applications at multiple authoritative centers in China, fully demonstrating the independent innovation and industrialization capabilities of Chinese medical device enterprises in the high-end electrophysiology field.

Professor Qin Mu further elaborated on the characteristics and applicable scenarios of pulsed ablation catheters of different sizes. Among them,The 10-mm large-tip focal catheter demonstrates superior performance in linear ablation (e.g., tricuspid isthmus and mitral isthmus), whereas the 15-mm, 20-mm, and 25-mm circular catheters are more suitable for pulmonary vein isolation, posterior wall isolation, and patch ablation.Drawing on specific case studies, he demonstrated the re-ablation strategy using this catheter in patients with recurrent atrial fibrillation after initial ablation, highlighting its ability to achieve precise conduction block even in complex electrophysiological substrates, such as recovered pulmonary vein potentials and restored conduction across the mitral isthmus.

Furthermore, Professor Qin emphasized the importance of intraoperative catheter selection and combined use. For instance, in a case of mitral isthmus ablation, bidirectional block was not achieved after 10 energy deliveries with a 15-mm catheter; however, after switching to a 10-mm large-focal catheter, bidirectional block was accomplished with only 4 energy deliveries. He believes that the RhythPulse®-PFA catheter not only offers highly efficient immediate ablation capabilities but also provides new tools and strategic insights for the individualized treatment of complex atrial arrhythmias.

Professor Sun Jian provided a detailed demonstration of various contact and ablation strategies using the circular pulsed field ablation catheter. For instance, when achieving adequate contact on the anterior wall of the right superior pulmonary vein is challenging, a “side-contact plus selective electrode activation” approach can be employed; for the posterior wall, a “stamp-like” contact technique is recommended to enhance stability. During tricuspid isthmus ablation, adjustable deflectable sheaths can facilitate either “side-contact” or “catheter straightening” maneuvers to avoid entanglement with chordae tendineae, thereby improving ablation efficiency. He also specifically highlighted that intraoperative electric field interference may cause “pseudo-displacement” artifacts in three-dimensional mapping systems, and that activating only selected electrodes can effectively confine such interference to the vicinity of the active electrodes, ensuring accurate localization.

Furthermore, Professor Sun emphasizedRhythPulse®-PFA Catheter Features the Unique Advantage of Patented Unilateral Coated Electrodes: Discharge Occurs Only at the Myocardial Contact Surface, Reducing Ineffective Blood Discharge, Thereby Lowering the Risk of Hemolysis and Microbubble Formation, and Enhancing the Safety of Procedures Such as Posterior Wall Isolation。Professor Sun Jian further validated the operational experience of the RhythPulse® catheter in arrhythmia procedures through five cases, providing practical evidence for the clinical promotion of PFA technology.

Professor Shi Ruizheng, Xiangya Hospital of Central South University"Advantages of the Novel Pulsed Ablation Energy Catheter RhythPulse®-PFA in the Clinical Treatment of Atrial Fibrillation" systematically elaborates on the iteration and improvement of PFA technology compared to traditional radiofrequency ablation. He pointed out that, as a non-thermal ablation energy source, PFA can selectively damage cardiomyocytes while preserving surrounding tissues such as blood vessels, nerves, and the esophagus, offering superior safety profiles for perivascular structures, the esophagus, and the phrenic nerve.

Professor Shi focused on introducingUnique Design Advantages of the RhythPulse®-PFA Circular Catheter。This catheter is developed based on a mature mapping catheter platform, compatible with mainstream 3D mapping systems, and features a gentle learning curve. Its circular electrode array can flexibly adapt to varying pulmonary vein anatomies, enabling segmental pulmonary vein isolation; transmural lesions can be achieved with minimal rotational overlapping. Notably,RhythPulse®-PFA circular catheter features an exclusive patented unilaterally coated electrode that delivers energy solely from the outer myocardial contact surface, effectively reducing ineffective discharge into the blood.，thereby reducing the risk of hemolysis and acute kidney injury.

Drawing on the application case at Xiangya Hospital, Professor Shi concluded that PFA has become the preferred energy source for nearly half of atrial fibrillation ablation centers in Europe. As China’s first unilaterally coated electrode-targeted ablation catheter, RhythPulse®-PFA features an exclusive 10mm specification that can also serve as a large-focal catheter for linear ablation, providing a “Chinese solution” that balances safety and efficacy for complex atrial arrhythmias.

The discussion session was hosted by the Union Hospital Affiliated to Fujian Medical UniversityProf. Zhang Feilong, Shanghai Sixth People's HospitalProfessor Huang Dong, Shanghai Pudong New Area People's HospitalProfessor Han SuxiaServe as a panelist for discussion.

Experts engaged in in-depth discussions and exchanges based on the presentations delivered by the aforementioned lecturers, sharing their respective experiences and insights from multiple perspectives. The frequent clash of ideas sparked further intellectual inspiration, effectively promoting the integration and elevation of academic viewpoints.

The conference was a resounding success, fully demonstrating the superior performance and stability of PFA technology in real-world clinical settings, marking a critical step forward in the regional promotion of comprehensive atrial fibrillation treatment technologies.