SHANGHAI, Feb. 28, 2023 /PRNewswire/ -- Pulnovo Medical Limited, a globally recognized OTM platform, announced positive one-year results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study at the industry's most leading American Cardiovascular Research Technologies conference (CRT 2023). PADN is an innovative radiofrequency ablation technique in treating PH, was recognized as a CFDA innovative medical device in 2018, and designated as a "breakthrough device "by the US FDA in 2021. The data from the PADN-CFDA pivotal study provides strong evidences for the treatment of pulmonary arterial hypertension.
Pulmonary arterial hypertension (PAH), or Group I pulmonary hypertension classified by the World Health Organization, is a progressive and incurable disease that can lead to premature death. The PADN-CFDA one-year follow-up shows positive results for improving patients' quality of life, which significantly aids in the treatment of pulmonary arterial hypertension (PAH).
A novel catheter-based procedure known as PADN has been successfully used to treat PAH patients by improving their exercise tolerance and hemodynamic parameters. This has been further supported by the PADN-CFDA study, which showed significant improvements in exercise capacity, hemodynamic parameters, and clinical outcomes in PAH patients six months after the PADN treatment. The result was published in JACC: Cardiovasc Interv in 2022. Prior to this study, there had been no multi-center, randomized or sham clinical trials evaluating the efficacy of PADN one year after procedure.
Professor Chen Shaoliang from Nanjing First Hospital of Nanjing Medical University gave a presentation on a multicenter, randomized, blinded, sham-controlled clinical trial designed to evaluate the safety and efficacy of PADN for the treatment of PAH patients over the procedure of one year after surgery. The study enrolled 128 clinically stable PAH patients aged 18-70 years who had not used PAH-targeted drugs for at least 30 days, including 63 patients in the PADN group (PADN + PDE-5i) and 65 patients in the sham group (sham procedure + PDE-5i). As the primary endpoint, the PADN group showed a significant improvement in the change of 6-minute walk distance (6MWD) from baseline both 6 months and 1 year since the intervention. The sham group showed a decrease and worsen from baseline both 6 months to 1 year following the intervention. The PADN group considerably outperformed the sham group in terms of the change in 6MWD from baseline 1 year since the intervention (treatment effect: 81.2; 95% CI, 50.3-112.2; p<0.001).
The cumulative incidence of clinical worsening one year after PADN was one of the secondary outcomes, and it was considerably greater in the sham group compared to the PADN group (4.8%; HR 0.19; 95% CI 0.06 to 0.66; adjusted HR 0.17; 95% CI 0.05 to 0.60). Other indicators, including the worsening of PAH, PAH-related rehospitalization, WHO-FC IV or increase by ≥1 grade, and the requirement for additional treatments, were significantly higher in the sham group than in the PADN group.
According to the analysis of the PADN-CFDA 1-year follow-up data, treatment with PADN plus a PDE-5i was associated with a further increase in 6-minute walk distance after 6-month until to one-year follow-up compared with PDE-5i treatment alone. In addition, treatment with PADN reduced PVR and PAP, improved right ventricular function, reduced tricuspid regurgitation and NT-proBNP levels, and improved clinical outcomes during one-year follow-up.
Professor Chen also gave presentations on "Pulmonary Artery Denervation-Updates from Experimental and Clinical Studies" and "Treatment Effects of Pulmonary Artery Denervation for Pulmonary Arterial Hypertension Stratified by Reveal Risk Score- Results from PADN-CFDA Trial". A review of several PADN pilot studies as well as clinical findings led to the conclusion that, in patients with different etiologies of PH, PADN significantly improved exercise capacity, hemodynamics, and clinical outcomes. Further analyzing the results of the PADN-CFDA study from a risk stratification perspective, Professor Chen noted that In patients with PAH, PADN plus PDE-5i significantly improved exercise capacity, NT-proBNP, hemodynamics, and clinical outcomes during the 6-month follow-up among intermediate-high risk patients.
About PADN series trials
Based on the importance of sympathetic hyperactivation in the progression of pulmonary hypertension (PH), in 2012 Professor Chen Shaoliang proposed PADN, a minimally invasive procedure that involves radiofrequency ablation through the femoral vein into the pulmonary artery to effectively damage the sympathetic nerves around the pulmonary artery and improve the pressure response of pulmonary artery traction receptors. Over the past decade, the results of the PADN-1 Phase I, PADN-1 Phase II and PADN-5 studies conducted by Professor Chen Shaoliang's team have been published, providing more evidence-based medical evidence on the safety and efficacy of PADN.
About Pulnovo Medical Limited
Pulnovo Medical Limited, a Global OTM Innovative Platform, is a globally recognized device pioneer in the treatment for cardiopulmonary diseases. Established in 2013 and rooted in innovation, Pulnovo Medical upholds evidenced-based research and translational medicine, and starts our research and development efforts alongside physicians at the operating table with the goal to market our innovative therapeutic solutions and benefit patients around the world.
