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02 December
178
In March 2013, the Department of Cardiology，Nanjing First Hospital，Nanjing Medical University，Department of Cardiology, Nanjing Heart Center，School of Public Health, City University of New York and Division of Cardiology, Beth Israel Medical Center，published a research that successfully demonstrated the benefits of PADN in the fight against pulmonary hypertension.Those results were published in the Journal of EuroIntervention.
Pulmonary arterial hypertension (PAH) is defined as a group of diseases characterised by a progressive increase in pulmonary vascular resistance resulting in right heart failure and premature death.There is no cure for PAH and it remains a life-threatening disorder although these therapies improve symptoms, haemodynamics and outcomes.The pathogenesis of PAH is complicated and still largely unknown.
Study Design
Briefly, twenty Mongolian dogs were randomly assigned to one of two groups: group 1 (left distal pulmonary basal trunk occlusion), and group 2 (left pulmonary interlobar artery occlusion). The occlusion model was conducted by the use of a balloon to stop the distal blood flow completely. Haemodynamic parameters were measured before and after balloon occlusion using a Swan-Ganz pulmonary artery catheter (Baxter Healthcare Corp., Irvine, CA, USA). The effect of PADN at the main pulmonary artery bifurcation level was investigated by repeating the above-mentioned procedure followed by left pulmonary interlobar artery occlusion.
Study Conclusion
The researchers hypothesised that experimental pulmonary hypertension can be caused by a reflex mechanism from balloon occlusion of the pulmonary artery. From this experimental study, researchers reported for the first time that: (1) occlusion of the left pulmonary interlobar artery rather than the left pulmonary basal trunk by balloon inflation induced significant increases of PAP and RVP; (2) PADN at the main bifurcation area of the pulmonary artery using a dedicated ablation catheter might completely abolish the pulmonary artery pressure response to the inflated balloon occlusion.They are the first to report that pulmonary artery denervation in the main pulmonary artery bifurcation area with our newly designed system might completely abolish the experimental pulmonary hypertension response to balloon inflations.
Clinical Implications
Although medical therapy for PAH was evaluated extensively, the chronic treatment of PAH remains unsatisfactory. Symptomatic improvement is not always possible. Once the diagnosis of pulmonary hypertension is established, the prognosis remains poor. As a result,this novel PADN treatment in the present study may provide new hope for therapeutics in patients with PAH.Researchers are the first to report that pulmonary artery denervation in the main pulmonary artery bifurcation area with our newly designed system might completely abolish the experimental pulmonary hypertension response to balloon inflations.
About PADN
PADN (Pulmonary Artery Denervation) is a groundbreaking and highly innovative radiofrequency ablation device for the treatment of pulmonary hypertension (PH). A potential first-in-class and best-in-class device, PADN uses vascular intervention to ablate the pulmonary sympathetic nerve, effectively reducing pulmonary artery pressure and slowing the progression of the disease.
The innovative nature of PADN is underscored by its designation as a Breakthrough Device by the US FDA in 2021, a recognition reserved for devices that have the potential to offer more effective treatment for life-threatening or irreversibly debilitating conditions. In 2023, the PADN received FDA Humanitarian Use Device (HUD) certification and National Medical Products Administration (NMPA) approval, highlighting its promise in the treatment of PH conditions.
About Pulnovo Medical
Pulnovo Medical Limited, is a globally recognized device pioneer in the treatment for pulmonary hypertension and heart failure. Established in 2013 and rooted in innovation, Pulnovo Medical is committed to leveraging our deep expertise in the science of breakthrough technologie with the goal to market our innovative therapeutic solutions and benefit patients around the world.www.pulnovomed.us
Journal of EuroIntervention
DOI:
10.4244/EIJV9I2A43
Percutaneous pulmonary artery denervation completely abolishes experimental pulmonary arterial hypertension in vivo
March 2013