Pulnovo’s PADN-HF-PH Trial Results Presented and Published

September 18, 2026—Pulnovo Medical, a China-based developer of medical devices for pulmonary hypertension (PH) and heart failure (HF), announced that results from the PADN-HF-PH trial were presented at the European Society of Cardiology’s ESC Congress 2026 and simultaneously published by Hang Zhang, MD, et al in The New England Journal of Medicine.

Pulnovo stated that the multicenter, 264-patient PADN-HF-PH randomized controlled trial is designed to evaluate the safety and clinical efficacy of adding pulmonary artery denervation (PADN) to guideline-directed medical therapy (GDMT) for patients with pulmonary hypertension associated with left heart disease (PH-LHD).

According to the company, the primary outcome was a composite of clinical worsening events—defined as death, heart or lung transplantation, hospitalization for heart failure, outpatient worsening of heart failure leading to intravenous diuresis, or a significant decline in the 6-minute walk distance (6MWD).

As summarized in Pulnovo Medical’s press release, key findings included a Kaplan-Meier estimated 2-year incidence of clinical worsening of 25.7% in the PADN-plus-GDMT group versus 51.5% in the GDMT-alone group (hazard ratio, 0.49; 95% CI, 0.30-0.82; P = .006). The effect was sustained through the follow-up period.

Additionally, there was a decrease in recurrent clinical events. For first-plus-recurrent events of clinical worsening, the annualized rate was 36.3 per 100 patient years in the PADN group versus 56.3 per 100 patient-years in the GDMT group. This equates to a 35.5% decrease in the annualized rate of recurrent events (hazard ratio, 0.59; 95% CI, 0.39-0.89).

The company further stated that the study showed PADN resulted in improved functional capacity and health status. At 12 months, patients achieved a net improvement of 24.8 meters in the 6MWD. Specifically, the risk of experiencing a ≥ 10% decrease in the 6MDW was reduced by 63% (hazard ratio, 0.37; 95% CI, 0.15-0.92).

Improvements in exercise capacity, health status, and ventricular function provided strong internal consistency. PADN resulted in an improved health status as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score.

At 6 months after the procedure, patients demonstrated a greater reduction in NT-proBNP levels from baseline compared to those receiving GDMT alone.

A favorable safety profile was demonstrated with access-site hematomas occurring in only two patients in the PADN group and in one patient in the GDMT group. There were no other procedural complications, stated Pulnovo Medical.