Clinical outcomes from 264 PH-LHD patients demonstrate a 51% reduction in the risk of clinical worsening, a 35.5% decrease in recurrent clinical events, and sustained concurrent improvements in functional capacity, supporting the multi-dimensional therapeutic benefits of the Pulmonary Artery Denervation (PADN) System.
SHANGHAI, Sept. 3, 2026 /PRNewswire/ -- Pulnovo Medical announced that groundbreaking results from the PADN-HF-PH trial were officially presented during the Hot Line 6 session at the European Society of Cardiology (ESC) Congress 2026 and simultaneously published in The New England Journal of Medicine (NEJM). The NEJM paper features Professor Shao-Liang Chen of Nanjing First Hospital, Academician Yaling Han of the General Hospital of Northern Theater Command, and Professor Gregg W. Stone of Mount Sinai Hospital as co-corresponding authors. This highly anticipated publication marks a watershed moment for cardiovascular interventions, providing high-quality clinical evidence that charts the course for the next generation of global, evidence-based therapeutic strategies in heart failure management.
The PADN-HF-PH trial is a multicenter, randomized, controlled clinical trial involving 264 patients, led by Academician Yaling Han of the General Hospital of Northern Theater Command. The trial was 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).
For patients suffering from PH-LHD, pulmonary hypertension and left-sided heart disease mutually exacerbate one another, leading to a higher symptom burden and poor clinical outcomes. Currently, treatments for PH-LHD primarily revolve around the underlying left heart condition. While GDMT improves the overall prognosis for heart failure patients, there remains a critical lack of approved, specific therapies targeting the pulmonary hypertension itself.
Summary of Key Findings:
- 51% Reduction in Risk of Clinical Worsening: During a median follow-up of 338 days, the Kaplan-Meier estimated 2-year incidence of clinical worsening was 25.7% in the PADN plus GDMT group, compared to 51.5% in the GDMT alone group.
- Highly Significant Primary Endpoint Outcome: This represents a 51% reduction in the risk of clinical worsening (hazard ratio, 0.49; 95% confidence interval, 0.30 to 0.82; P=0.006). The effect was sustained through the follow-up period, which is clinically relevant for this chronic, progressive disease.
- Comprehensive Improvement in Composite Metrics: The primary outcome was a rigorous 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. This holistic evaluation reflects the true changes in a patient's long-term disease state.
- 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.
- Overall Disease Burden Reduction: This equates to a 35.5% decrease in the annualized rate of recurrent events (hazard ratio, 0.59; 95% CI, 0.39 to 0.89), suggesting that PADN modifies the overall disease burden rather than simply delaying the first event.
- Protection Against Functional Decline (6MWD): PADN resulted in improved functional capacity and health status. At 12 months, patients achieved a net improvement of 24.8 meters in their 6-minute walk distance. Specifically, the risk of experiencing a 10% or greater decrease in the 6-minute walk distance was reduced by 63% (hazard ratio, 0.37; 95% CI, 0.15 to 0.92).
- Concordant Improvements in Quality of Life (KCCQ) and Biomarkers (NT-proBNP): Concordant 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 (KCCQ-OSS). At 6 months after the procedure, patients demonstrated a greater reduction in natriuretic peptide (NT-proBNP) levels from baseline compared to those receiving GDMT alone.
- Favorable Safety Profile: The procedure demonstrated favorable safety, 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.
The robust, multi-dimensional evidence generated by the PADN-HF-PH trial is set to establish a new clinical paradigm. By comprehensively reducing clinical worsening, lowering recurrent event rates, and improving functional status and key biomarkers, the trial provides critical new evidence for treating PH-LHD patients.
About Pulmonary Artery Denervation
Pulnovo's proprietary Pulmonary Artery Denervation (PADN) is a minimally invasive therapy designed to modulate overactivated sympathetic nerve activity that contributes to pulmonary vascular remodeling and cardiopulmonary disease progression.
The therapy has been recognized in multiple international clinical guidelines, including its inclusion as an investigational interventional therapy in the 2022 European Society of Cardiology (ESC) / European Respiratory Society (ERS) Guidelines for the diagnosis and treatment of pulmonary hypertension, and has been referenced in a total of seven clinical guidelines to date.
Clinical investigation of the PADN procedure is ongoing across multiple subtypes of pulmonary hypertension. Building upon its regulatory approvals in 12 countries/regions and clinical experience of approximately 1,500 procedures in WHO Group 1 PH. Pulnovo Medical is expanding its clinical investigation of the therapy into WHO Group 2 PH associated with Left Heart Disease (PH-LHD) to address the significant unmet clinical needs of this broader patient population.
About Pulnovo Medical
Pulnovo Medical is an innovative medical technology company dedicated to advancing interventional therapies for pulmonary hypertension and heart failure. Driven by clinical value, the company is developing breakthrough solutions based on its proprietary technology platform, with a focus on global clinical development and commercialization to improve patient outcomes worldwide. For more information, please visit www.pulnovomed.com.
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