Safety-Focused

Key Scientific Milestones

Insight Lifetech’s nanosecond PFA system is the first PFA system with randomized controlled trial (RCT) evidence supporting the entire procedure under local anesthesia. Results from the InsightPFA Trial, which compared Insight Lifetech’s nanosecond PFA system with AI-guided RFA, were selected for the Late-Breaking Clinical Trials session at the ESC Congress 2025 and published in the JACC in 2025, demonstrating the clinical value of nsPFA technology.[3] Insight Lifetech’s nanosecond PFA system is also the only Chinese-developed product included in the 2026 HRS/EHRA Joint Scientific Statement on Pulsed Field Ablation for Cardiac Arrhythmias, issued by the HRS and the EHRA.[4]

References

[1][2][3]Lin, W., Chu, H., Wang, C., Chang, D., Yin, X., Wang, Y., Jiang, C., Xu, Y., Liao, Q., Yang, J., Zhu, W., Li, S., Gao, W., Chen, Y., Yu, Y., Li, Q., Liao, H., Deng, H., Wei, W., Pu, S., Guo, Z., Xu, D., Li, W., Ouyang, F., & Xue, Y. (2025). Pulsed Field Ablation Using a Novel Biphasic Catheter vs Thermal Ablation for Paroxysmal Atrial Fibrillation: InsightPFA Trial. Journal of the American College of Cardiology, 86(23). https://doi.org/10.1016/j.jacc.2025.09.1593

[4]Verma, A., Hocini, M., Andrade, J., Gerstenfeld, E., Kapa, S., Lakkireddy, D., Miklavcic, D., Natale, A., Piccini, J., Schmidt, B., & Gunawardene, M. A. (2026). 2026 HRS/EHRA Scientific Statement on Pulsed Field Ablation for Cardiac Arrhythmias. Heart Rhythm. Published online 13 February 2026.