Pulnovo’s PADN System Receives Two IDE Approvals for Pulmonary Hypertension

September 12, 2025—Pulnovo Medical, a Shanghai, China-based developer of medical devices for pulmonary hypertension (PH) and heart failure, announced that its pulmonary artery denervation (PADN) catheter and generator received two investigational device exemption (IDE) approvals from the FDA.

According to the company, the first IDE is for a humanitarian device exemption (HDE) study approved for patients with group I PH (pulmonary arterial hypertension). The second IDE is for a premarket approval study for patients with group II PH (PH caused by left heart disease). The trials have full coverage approval from the Centers for Medicare & Medicaid Services (CMS).

The IDE approvals pave the way for the upcoming clinical trials in the United States that aim to validate the efficacy and safety of PADN technology in the treatment of group I and group II patients, advised Pulnova.

Additionally, the company stated that the IDE approvals, coupled with the full coverage by CMS, will advance the clinical application and market acceptance of the PADN system.

Pulnova noted that PADN has previously received FDA humanitarian-use device designation in the United States, regulatory approval from the National Medical Products Administration in China, and European CE Mark approval. Also, the FDA granted Breakthrough Device designation for the PADN technology for groups I, II, and IV PH in 2021.