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, according to results from the PADN-HF-PH trial presented at the European Society of Cardiology (ESC) 2026 Congress and published simultaneously in The New England Journal of Medicine (NEJM).
Trial of 264 patients shows 51% risk reduction over two-year follow-up
The multicenter, randomized controlled trial, led by academician Yaling Han of the General Hospital of Northern Theater Command, enrolled 264 patients with pulmonary hypertension associated with left heart disease (PH-LHD). Over a median follow-up of 338 days, the estimated two-year incidence of clinical worsening was 25.7% in the PADN-plus-GDMT group versus 51.5% in the guideline-directed medical therapy (GDMT)-alone group (hazard ratio 0.49; 95% CI, 0.30 to 0.82; p=0.006).
Recurrent clinical events drop 35.5% with PADN added to standard therapy
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 in the GDMT group, a 35.5% reduction (hazard ratio 0.59; 95% CI, 0.39 to 0.89). Researchers stated the data indicate PADN modifies overall disease burden rather than merely delaying the first event.
Functional capacity improves as 6-minute walk distance rises by 24.8 meters
At 12 months, patients receiving PADN achieved a net improvement of 24.8 meters in six-minute walk distance. The risk of a 10% or greater decline in walking distance was reduced by 63% (hazard ratio 0.37; 95% CI, 0.15 to 0.92). Concordant improvements were also recorded in quality-of-life scores via the Kansas City Cardiomyopathy Questionnaire and in NT-proBNP biomarker levels at six months post-procedure.
Safety profile shows minimal complications across procedure group
Access-site hematomas occurred in two patients in the PADN group and one patient in the GDMT group, with no other procedure-related complications reported.
Regulatory reach extends to 12 countries with 1,500 prior procedures
PADN, Pulnovo's proprietary minimally invasive therapy, has regulatory approval in 12 countries and regions and has been used in approximately 1,500 procedures for WHO Group 1 pulmonary hypertension. The therapy is referenced in seven clinical guidelines to date, including the 2022 ESC/European Respiratory Society guidelines as an experimental interventional therapy. Pulnovo is now extending clinical research into WHO Group 2 pulmonary hypertension associated with left heart disease, targeting a broader patient population with limited approved targeted therapies.
The NEJM paper lists Professor Shao-Liang Chen of Nanjing First Hospital, academician Yaling Han, and Professor Gregg W. Stone of Mount Sinai Hospital as corresponding co-authors.