Pulnovo’s PADN Catheter Receives CE Mark Clearance Under EU MDR

April 16, 2025—Pulnovo Medical, a China-based developer of medical devices for pulmonary hypertension (PH) and heart failure, announced that its pulmonary artery denervation (PADN) catheter for treating PH has received CE Mark clearance under the European Union Medical Device Regulation.

According to Pulnovo, the PADN catheter targets overactive sympathetic nerve activity to lower pulmonary artery pressure in patients with PH. Its clinical benefit has been demonstrated across multiple studies, noted the company.

In January 2024, the company announced it had received approval from China’s National Medical Products Administration for the PADN catheter and generator. Also, the product was granted Breakthrough Device designation by the FDA for Group I, Group II, and Group IV PH, and received approval for a humanitarian use device exemption in the United States. In early 2024, the PADN catheter was assigned a Category III CPT code to support its use in clinical practice in the United States, stated Pulnovo.

In March 2025, Pulnovo announced the closing of approximately $100 million Series C financing that will be used to advance the company’s international business expansion, strategic initiatives, and global clinical trials.