Pulnovo Medical Reports PADN Trial Results in NEJM

Shanghai, China, September 3, 2026

PADN-HF-PH Demonstrates Reduced Clinical Worsening

The PADN-HF-PH study was designed to determine whether adding pulmonary artery denervation to established medical treatment could improve outcomes for patients with PH-LHD. The condition represents a challenging form of pulmonary hypertension in which elevated pressure in the pulmonary circulation is associated with underlying left heart disease and heart failure. Patients can experience worsening exercise capacity, recurrent heart-failure events and substantial symptom burden, while treatment traditionally focuses on management of the underlying cardiac disease. In the randomized trial, the estimated two-year incidence of clinical worsening was 25.7% with PADN plus GDMT compared with 51.5% with GDMT alone. This corresponded to a hazard ratio of 0.49, with a 95% confidence interval of 0.30 to 0.82 and a P value of 0.006. The primary composite endpoint incorporated clinically important outcomes including death, heart or lung transplantation, heart-failure hospitalization, outpatient worsening requiring intravenous diuresis, or a significant decline in six-minute walk distance. The trial also indicated that the potential benefit of PADN extended beyond delaying the first clinical worsening event. The annualized rate of first and recurrent clinical-worsening events was 36.3 per 100 patient-years in the PADN group compared with 56.3 per 100 patient-years among patients receiving GDMT alone. This represented a 35.5% reduction in recurrent clinical events, with a hazard ratio of 0.59 and a 95% confidence interval of 0.39 to 0.89. These findings suggest that the intervention may influence the broader burden of disease in patients with PH-LHD, although additional evidence and longer-term follow-up will be important for establishing its role in clinical practice.

Pulnovo Medical Reports Functional and Health Benefits

Alongside the primary clinical outcome, PADN was associated with improvements in measures of functional capacity and patient health status. At 12 months, patients treated with PADN achieved a net improvement of 24.8 meters in six-minute walk distance compared with the control group. The risk of experiencing a 10% or greater decline in walking distance was also reduced by 63%, corresponding to a hazard ratio of 0.37 and a 95% confidence interval of 0.15 to 0.92. Investigators additionally reported improvements in the Kansas City Cardiomyopathy Questionnaire overall summary score, a measure of health status in heart-failure patients, together with greater reductions in NT-proBNP, a biomarker associated with cardiac stress. The consistency across clinical events, exercise capacity, health status and biomarkers provides multiple dimensions for evaluating the intervention’s effects. The reported safety findings were also favorable. Only two patients in the PADN group and one patient in the GDMT group experienced access-site hematomas, while no other procedural complications were reported in the trial results. The safety profile will remain an important consideration as pulmonary artery denervation continues to be evaluated, particularly because the procedure involves catheter-based intervention within the pulmonary arterial system. The current findings provide clinical evidence from a randomized controlled study, but they should be interpreted within the context of the trial population, follow-up period and study design.

NEJM Publication Advances Pulmonary Hypertension Research

The simultaneous presentation at ESC Congress 2026 and publication in NEJM represents an important scientific milestone for Pulnovo Medical and the PADN technology. The study provides randomized clinical evidence evaluating whether targeted pulmonary artery intervention can complement conventional heart-failure treatment in PH-LHD. Pulnovo’s Pulmonary Artery Denervation System is designed to interrupt sympathetic nerve activity around the pulmonary arteries, with the objective of reducing abnormal vascular and neurohormonal signaling associated with pulmonary hypertension. The PADN-HF-PH results therefore contribute to a growing body of research examining device-based interventions for cardiovascular disease where pharmacological treatment alone may not fully address the underlying pathophysiology. For the medical-device sector, the findings highlight the potential of interventional cardiovascular technologies to complement established medical management. The results do not by themselves establish PADN as a new standard of care, and regulatory status and guideline adoption remain separate considerations. Nevertheless, the demonstrated reductions in clinical worsening and recurrent events, together with improvements in functional capacity and health status, provide important evidence for continued investigation of pulmonary artery denervation in PH-LHD. The NEJM publication and ESC presentation may also help advance further research into patient selection, procedural optimization and the long-term clinical impact of PADN technology.

Source: Pulnovo Medical press release