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 its self-developed PADN catheter for treating pulmonary hypertension(PH) has officially received CE clearance under the European Union Medical Device Regulation (EU MDR).

The PADN catheter is used in pulmonary artery denervation procedures, targeting overactive sympathetic nerve activity to lower pulmonary artery pressure in patients with pulmonary hypertension. Its clinical benefit has been demonstrated across multiple studies.

In recent years, PADN has received multiple international recognitions. 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.

Cynthia Chen, Chairlady of Pulnovo Medical, added: “This marks not only a regulatory achievement, but a validation of our long-term commitment to clinical science and patient-centered innovation. With MDR approval in hand, PADN is now poised to reach more patients worldwide, bringing meaningful impact to the treatment of pulmonary hypertension.”

The successful MDR certification not only affirms the PADN catheter’s safety and effectiveness under Europe’s highest regulatory standards but also paves the way for broader international access and adoption. It further positions Pulnovo Medical as a committed leader in the field of pulmonary hypertension, driving innovation with clinical rigor and a global mindset.

About PADN
Pulmonary Artery Denervation (PADN) is a percutaneous pulmonary artery intervention procedure that uses a PADN catheter to deliver radiofrequency energy to the sympathetic nerves in the outer membrane of the pulmonary artery, resulting in the disappearance of the myelin sheath of the nerves and the fusion of the axons, which inhibits sympathetic activity, increases cardiac output, reduces pulmonary artery pressure , inhibits the pathologic remodeling of the pulmonary arteries, improves the patient's exercise endurance and cardiac function, and achieves long-term benefits from a single minimally invasive procedure.

About Pulnovo Medical

Founded in 2013, Pulnovo Medical Limited is a globally recognized leader in devices for the treatment of pulmonary hypertension and heart failure. Driven by innovation, Pulnovo is committed to advancing breakthrough technologies that offer therapeutic benefits to patients around the world.