Shanghai – September 08, 2026 -- Pulnovo Medical's pulmonary artery denervation (PADN) system reduced the risk of clinical worsening by 51% in patients with pulmonary hypertension linked to left heart disease (PH-LHD), according to results from the PADN-HF-PH trial presented at the European Society of Cardiology (ESC) Congress 2026 and simultaneously published in The New England Journal of Medicine.
Trial enrolled 264 patients across multiple centers under academician Yaling Han
The multicenter, randomized controlled study, led by academician Yaling Han of the General Hospital of Northern Theater Command, evaluated PADN as an add-on to guideline-directed medical therapy (GDMT) versus GDMT alone. Corresponding authors on the NEJM paper include Professor Shao-Liang Chen of Nanjing First Hospital and Professor Gregg W. Stone of Mount Sinai Hospital.
Two-year incidence of clinical worsening dropped to 25.7% from 51.5%
Over a median follow-up of 338 days, Kaplan-Meier estimated 2-year incidence of clinical worsening was 25.7% in the PADN-plus-GDMT arm versus 51.5% in the GDMT-only arm, a 51% risk reduction (hazard ratio 0.49; 95% CI 0.30-0.82; P=0.006). The composite primary endpoint captured death, heart or lung transplant, heart failure hospitalization, outpatient worsening requiring intravenous diuresis, or significant decline in 6-minute walk distance.
Recurrent clinical events fell 35.5% in the PADN cohort
Annualized rates of first and recurrent clinical worsening events were 36.3 per 100 patient-years in the PADN group versus 56.3 per 100 patient-years in the GDMT group, a 35.5% reduction in recurrence rate (hazard ratio 0.59; 95% CI 0.39-0.89).
Six-minute walk distance improved by 24.8 meters at 12 months
Patients receiving PADN showed a net 24.8-meter improvement in 6-minute walk distance after 12 months, with a 63% lower risk of a 10% or greater decline in walk distance (hazard ratio 0.37; 95% CI 0.15-0.92). Improvements in the Kansas City Cardiomyopathy Questionnaire overall summary score and steeper reductions in NT-proBNP levels at six months paralleled the functional gains.
Procedure recorded only minor safety events
Puncture-site hematomas occurred in two PADN patients and one GDMT patient, with no other procedure-related complications reported.
PADN has regulatory clearance in 12 countries with roughly 1,500 procedures completed
PADN has been referenced in seven international clinical guidelines, including the 2022 ESC/European Respiratory Society guidelines on pulmonary hypertension, where it is listed as an experimental interventional therapy. The device holds regulatory approvals in 12 countries and regions, with approximately 1,500 procedures performed to date in WHO Group 1 pulmonary hypertension patients. Pulnovo Medical is now expanding clinical investigation to WHO Group 2 pulmonary hypertension associated with left heart disease.