SHANGHAI, Sept. 12, 2025 /PRNewswire/ -- Pulnovo Medical, a globally recognized leader in medical devices for pulmonary hypertension (PH) and heart failure (HF), is proud to announce that its PADN catheter and generator has received two Investigational Device Exemption (IDE) approvals-HDE study approved for patients with Group I PH patients, PMA study approved for patients with Group II PH patients, with CMS full coverage approval, paving the way for upcoming clinical trials in the United States.
Following the FDA's BDD designation granted in 2021 for Groups I, II, and IV, the newly obtained IDE approvals will advance clinical studies targeting Groups I and II into the IDE stage. These trials focus on different patient groups-Group I (Pulmonary Arterial Hypertension, PAH) and Group II (PH due to left heart disease)-with the aim of validating the efficacy and safety of PADN technology in the treatment of these conditions. Both clinical trials are important for evaluating the use of PADN in diverse populations with pulmonary hypertension and heart failure. This IDE approval, coupled with the full coverage by CMS in the U.S., has significantly advanced the clinical application and market acceptance of the PADN system, providing critical data to support Pulnovo Medical's further commercialization efforts in the U.S.
PADN has received FDA HUD designation, is approved by the NMPA, and is CE-marked, meaning it meets high safety and efficacy standards globally. Pulmonary Artery Denervation (PADN) offers more options for both Group I pulmonary arterial hypertension patients with limited response to existing drug therapies and Group II pulmonary hypertension patients, who currently have no specifically approved treatment. With over 1,000 clinical applications across countries such as Portugal, Georgia, Singapore, Malaysia, and China, PADN products have consistently demonstrated a strong safety profile and therapeutic efficacy in real-world settings.
The IDE approval marks a critical step in Pulnovo Medical's commitment to delivering innovative, high-quality solutions for patients with pulmonary hypertension and accelerating the global expansion of PADN technology. The results of these studies will generate valuable data to further validate the potential of PADN. Progress in these clinical trials is expected to bring meaningful benefits to patients, including improved exercise tolerance in daily life and a better overall quality of life.
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