SHANGHAI, Sept. 7, 2022 /PRNewswire/ -- A globally recognized OTM innovative platform Pulnovo Medical Limited's proprietary Pulmonary Artery Denervation (PADN) technology has been included in the 2022 ESC/ERS Guidelines for the Diagnosis and Treatment of pulmonary arterial hypertension (PAH) (hereinafter referred to as "the Guidelines"), jointly issued by the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), at ESC Congress 2022.
The Guidelines will provide physicians and patient families with the best recommendations and the latest evidence for the diagnosis and treatment of PAH worldwide. The inclusion of PADN in the international guidelines not only demonstrates the significant academic value and clinical potential of PADN in the treatment of PAH, but also reflects the positive implications of this technology for the treatment and health management of patients with PAH.
The inclusion was endorsed by the International Society for Heart and Lung Transplantation(ISHLT) and the European Reference Network in rare respiratory disease(ERN-LUNG).
PAH is a pathophysiological syndromes characterized by elevated pulmonary artery pressure (PAP) and pulmonary vascular resistance, which may lead to heart failure and sudden death in severe cases.
PADN is a potential global first-in-class, best-in-class innovative radiofrequency ablation device for PAH. It received the Breakthrough Device Designation from the FDA in 2021. PADN is a vascular interventional ablation technology that uses radiofrequency ablation to block pulmonary intima sympathetic nerves and reduce pulmonary artery pressure to delay disease progression.
The Guidelines include an introduction and analysis of the PADN technique as part of the treatment for PAH. The technique was formally introduced in 2012 by Dr. Shaoliang Chen, Chair of Pulnovo Medical Limited's Scientific Advisory Board and pioneer of the PADN technology , and is considered to have great potential in the treatment of PAH.
Based on the proposed technique, Dr. Chen's team conducted the first PADN animal experiment on 20 dogs in the same year. The results showed that the pressure responses were completely abolished by the PADN treatment at the main bifurcation area of the left pulmonary artery.
After obtaining the expected results in animal studies, the team successively conducted a series of PADN clinical trials including PADN1-Phase1, PADN1-Phase2 and PADN5 to explore the safety and efficacy of PADN in WHO Group1, Group2 and Group4 patients with PH. Clinical results showed that PADN was feasible for the treatment of PH. Also, it significantly improved hemodynamic status, cardiac function and exercise capacity, while reducing PH-related events and mortality one year after PADN treatment in patients, including those with IPAH who did not respond optimally to drug therapies.
The PADN-CFDA study led by Dr. Chen's team has been completed. The single-blind, randomized, sham-operated controlled clinical study is designed to evaluate the safety and efficacy of PADN surgery for PAH. The preliminary clinical data disclosed so far has been positive, and the final PADN-CFDA clinical results are expected to bring more pleasant surprises to health care practitioner to fullfill this unmet medical needs in PAH.
To date, Dr. Chen's team has undertaken several trips to Europe, the United States and Asia for theoretical teaching and surgical demonstrations and provided on-site guidance to surgeries taking place during their visits. During the trips, Dr. Chen's team also delivered more than 20 internationally invited academic presentations, all of which garnered much attention worldwide.
The latest clinical results of the PADN-CFDA study will be presented on September 18 (11:45 AM 11:55 AM EDT) at the TCT 2022 (Transcatheter Cardiovascular Therapeutics 2022) LBCT session （Late Breaking Trial). In addition, an international multi-center PADN Global Clinical Trial, with Prof. Gregg W. Stone, the cardiovascular expert as principal investigator (PI), is scheduled to be launched soon with the goal of providing more evidence-based medical support for PADN technology, while at the same time, providing new solutions for the treatment of PAH. Looking ahead, PADN will continue to be committed to helping patients with breakthrough therapies driven by clinical value, focusing on hard-core innovation and advocating for local development of medical devices.
