SHANGHAI, Sept. 23, 2022 /PRNewswire/ -- Pulnovo Medical Limited, a globally recognized OTM platform, today announced the positive results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study on the world's largest and most influential American transcatheter cardiovascular therapy conference (TCT 2022). 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 .
About PADN-CFDA Results
The PADN-CFDA study was a multicenter, randomized, blinded, sham-controlled clinical trial designed to evaluate the effectiveness and safety of the PADN surgical instrumentation system applied to patients with pulmonary artery denervation for pulmonary hypertension. 128 patients with PAH (mean pulmonary artery pressure ( mPAP) ≥25 mm Hg, pulmonary capillary wedge pressure (PAWP) <15 mm Hg, PVR >3.0 WUs) and were randomized 1:1 to the PADN group (PADN + phosphodiesterase-5 inhibitor, n=63) and the sham-operated group (sham-PADN + phosphodiesterase-5 inhibitor, n=65), with no patients in either group having used at least 30 days prior to enrollment had been treated with PAH-specific medication.
The results showed that 6MWD improved in both groups during the follow-up period, with significant differences between groups at 30 days postoperatively. 6MWD in the PADN and sham-operated groups, the change from baseline at 6 months postoperatively was 56.9 ± 5.6 m and 26.7 ± 5.4 m, respectively, and the median change (IQR) was significantly higher in the PADN group than in the sham-operated group (61.0 m vs. 18.0 m, p=0.004). At 6 months postoperatively, the group-corrected mean difference in 6MWD change was 33.8 m (95% CI 16.7-50.9; p<0.001), which was significantly better in the PADN group. In addition, the proportion of patients with increased 6MWD was higher in the PADN group than in the sham-operated group (81.4% vs. 61.5%).
From baseline to 6 months PVR was reduced by -3.0 ± 0.3 Wood units after PADN and -1.9 ± 0.3 Wood units after sham (adjusted difference -1.4, 95% CI -2.6 to -0.2). PADN also improved right ventricular function, reduced tricuspid regurgitation and decreased NT-proBNP. Clinical worsening was less (1.6% vs. 13.8%; OR 0.11 , 95% CI 0.01 to 0.87) and a satisfactory clinical response was greater (57.1% vs. 32.3%; OR 2.79 , 95% CI 1.37 to 5.82) with PADN treatment during 6-month follow-up.
This study suggests that PADN combined with a phosphodiesterase-5 inhibitor is effective in improving hemodynamics, exercise tolerance and clinical prognosis in patients with pulmonary hypertension, and the rate of clinical deterioration was less than in the sham-operated group. the publication of data from the PADN-CFDA study provides strong evidence for PADN to move from research to the clinic.
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.