Positive one-year results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study.
About PADN series trials
Based on the importance of sympathetic hyperactivation in the progression of pulmonary hypertension (PH). PADN, a minimally invasive procedure was proposed 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.
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 evidence for the treatment of pulmonary arterial hypertension.
A presentation was given 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 worsened 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).
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. For more information visit: Pulnovo Medical
Source: Reprint courtesy of PRNewswire, Image courtesy of Pulnovo Medical