Pulnovo Medical Announces PADN Receives FDA HUD Designation and US CMS Medicare Coverage Code and NMPA Approval
SHANGHAI, Jan. 2, 2024 /PRNewswire/ -- Pulnovo Medical Limited, a globally recognized device pioneer in the treatment of Pulmonary Hypertension (PH) and Heart Failure (HF), recently announced that it has successfully obtained Humanitarian Use Device (HUD) designation from the US FDA and approval from China's National Drug Administration (NMPA) for the PADN Catheter and Generator. The PADN technology is a major revolutionary procedure in the field of global interventional pulmonary arterial hypertension (PAH), which breaks the dilemma in PAH interventional therapy.
Meanwhile, PADN Catheter and Generator has recently been endorsed by the American Medical Association (AMA) and approved by the US Medicare & Medicaid Services (CMS) to receive an important Medicare coverage code.
About PAH
Pulmonary Arterial Hypertension (PAH) is a clinical and pathophysiological syndrome caused by structural or functional changes in the pulmonary vasculature due to a variety of heterogeneous diseases and different pathogenic mechanisms, resulting in increased pulmonary vascular resistance and pulmonary arterial pressure, and subsequent development of right heart failure and even death. Because of its severe impact on patients' quality of life and high mortality risk, it has been called the "cancer" of cardiovascular disease.
With limited treatment options, some patients are unable to meet their treatment expectations and there is an urgent need for newer and more effective therapies to address this clinical challenge. In recent years, with in-depth research into the pathogenesis of pulmonary hypertension, innovative therapies supported by evidence-based medicine have led to the development of new guidelines in the field of pulmonary hypertension, providing the most up-to-date diagnostic and therapeutic basis for contemporary clinical practice. The introduction of new drugs, the rise of interventional therapies, in particular the application of pulmonary artery denervation (PADN) technology in clinical practice, and the good results of clinical trials have overcome the dilemma of pulmonary arterial hypertension, which has long relied on targeted drug therapy to improve symptoms, and have brought the treatment of PAH into a whole new era, with more treatment options and a better prognosis for patients.
About PADN
The PADN catheter and generator, originally developed by Pulnovo Medical, are an innovative "First-in-Class" Pulmonary Hypertension interventional devices, which consists of a Multi-pole Pulmonary Artery RF Ablation Catheter and a Multi-pole Pulmonary Artery RF Ablation Generator. After ten years of innovation and research, PADN-1 Phase Ⅰ, PADN-1 Phase Ⅱ, PADN-5 and other studies have been carried out with more than 400 patients, providing evidence-based medical evidences for the safety and efficacy of PADN, which is supported and recognized by experts at home and abroad.
PADN is a potential global first-in-class, best-in-class innovative radiofrequency ablation device for treating pulmonary arterial hypertension (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. In August 2022, PADN was included in the international ESC guidelines for the first time, which affirmed the improvement of clinical outcomes of PH patients after PADN.
About Pulnovo
Pulnovo Medical Limited, is a globally recognized device pioneer in the treatment for heart failure. Established in 2013 and rooted in innovation, Pulnovo Medical is committed to leveraging our deep expertise in the science of breakthrough technology with the goal to market our innovative therapeutic solutions and benefit patients around the world.
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SOURCE Pulnovo Medical
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