Shanghai, China – April, 2025 – Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), is proudly to announce that it has recently obtained its second EU market approval, following the earlier approval of its innovative catheter device at euroPCR.

With both the catheter and generator now CE-MDR certified, Pulnovo Medical has achieved a significant milestone in its internationalization change to globalization. The PADN system, developed for the treatment of pulmonary hypertension, combines a precision-engineered catheter with a high-performance RF ablation generator. This minimally invasive therapy targets the pulmonary sympathetic nerves to reduce pulmonary artery pressure and improve patient outcomes.

In recent years, PADN has received recognition across major markets. In the United States, the product was granted Breakthrough Device Designation by the FDA for Group I, Group II, and Group IV pulmonary hypertension, and later received Humanitarian Use Device (HUD) approval. In early 2024, PADN was also assigned a Category III CPT code, supporting its advancement into clinical practice in the U.S. In China, PADN received approval from the National Medical Products Administration (NMPA), further validating its clinical safety and performance, and has since commenced commercial sales.