SHANGHAI, Jan. 1, 2022 /PRNewswire/ — Pulnovo Medical Limited, a globally recognized device pioneer in treatment for cardiopulmonary disease, today announced the positive results from the Pulmonary Artery Denervation (PADN)-CFDA pivotal study, being the first global completed pulmonary hypertension treatment device RCT study. 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 meet the primary efficacy and safety endpoint.
Pulmonary Hypertension is defined as an increase in mean pulmonary arterial pressure (PAPm) ≥25 mmHg at rest as assessed by right heart catheterization (RHC), caused by different etiologies, which eventually lead to the right heart increased load, right heart failure and sudden death. The term PAH describes a group of PH patients characterized hemodynamically by the presence of pre-capillary PH, defined by a pulmonary artery wedge pressure (PAWP) ≤15 mmHg and a PVR.
As a pathological phenomenon, pulmonary hypertension includes a variety of diseases, such as left heart disease, lung disease, chronic pulmonary thrombosis and others. Many has considered PH as the “cancer” of cardiovascular disease, due to its low chance of survival rate. Without proper treatment, the average life span of patients is estimated to be 2.8 years.Previously, the existing treatments for patients with pulmonary hypertension mainly relied on targeted drugs and lung transplantation.
PADN is a potential global first-in class, best-in class innovative radiofrequency ablation device in treating PAH. It was designated as “breakthrough device” by the US FDA in 2021. PADN is a vascular interventional ablation that uses radiofrequency ablation to block the pulmonary intima sympathetic nerve and reduce pulmonary artery pressure to delay disease progression.
Because of its pioneering nature, PADN has captured the attention from the medical experts from the cardiovascular and respiratory field. During the 2021 Transcatheter Cardiovascular Therapeutics Conference, Dr. Gregg W. Stone, TCT Conference Chairman and one of the world’s leading cardiovascular experts, announced that he will lead a group of global pulmonary hypertension and cardiovascular experts to launch a pivotal trial in 2022, being the first global PADN multicenter pivotal trial.
About Pulnovo Medical Limited
Pulnovo Medical Limited, a Global OTM Innovative Platform, is a globally recognized device pioneer in treatment for cardiopulmonary disease.
The first core product, PADN catheter, a potential global first-in-class device, was recognized as a CFDA innovative medical device in 2018, and designated as a “breakthrough device” by the US FDA in 2021. These recognitions are testaments to our pioneering innovative capabilities also allow for prioritizing in subsequent regulatory submission review.
Established in 2013, Pulnovo Medical starts our research and development effort at the operating table by doctors with the goal to market for patients.
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SOURCE Pulnovo Medical