Pulmonary Hypertension Breakthrough: Pum Tech Completes Enrollment in Landmark PADN-CFDA Trial for Innovative PADN Therapy System
Pulmonary arterial hypertension, often referred to as the “cancer of cardiovascular diseases” due to its exceptionally high morbidity and mortality rates, affects nearly 100 million patients worldwide. Yet, it remains one of the lesser-known malignant conditions. Previously, only two treatment options were available for patients with pulmonary hypertension: pharmacological therapy and lung transplantation. Statistics indicate that the annual cost of medication for pulmonary hypertension is approximately $80,000, a financial burden unbearable for the vast majority of patients. Lung transplantation, meanwhile, is fraught with challenges due to the severe scarcity of donor organs, the high risk of postoperative complications such as infections and rejection, and the necessity for long-term immunosuppressive therapy. In addition to these clinical hurdles, the prohibitive cost of surgery further deters many patients from pursuing this option.
A multicenter, randomized, blinded, sham-controlled clinical trial sponsored by PAM Medical to evaluate the efficacy and safety of the PADN device system when applied in percutaneous pulmonary artery denervation (PADN) for the treatment of patients with pulmonary hypertension: PADN-CFDA (hereinafter referred to as the PADN Study). The study primarily assesses the efficacy and safety of the PADN device system in performing percutaneous pulmonary artery denervation (PADN) for patients with pulmonary hypertension.Pamu Medical’s self-developed ablation product (PADN procedure device) rapidly secured FDA Breakthrough Device designation in just 16 days in early 2021, marking the first such achievement by a Chinese company in the field of pulmonary hypertension!
The PADN study was officially launched in January 2018. Spanning three and a half years, and with strong support from ten leading hospitals across China, it successfully completed the enrollment of 128 patients on June 22, 2021. In accordance with the study protocol, Pama Medical will continue to assist the participating centers in conducting follow-up visits for enrolled patients, retrieving data, and performing data cleaning. The company will also actively cooperate with the National Clinical Research Center to complete subsequent tasks. We look forward to the early publication of the PADN study results, which will provide a reliable evidence base for the treatment of patients with pulmonary hypertension and showcase high-quality original research findings from China to the world.
As the only one in the field of pulmonary hypertension to receiveFDA BreakthroughPamu Medical, grounded in innovation and dedicated to pulmonary arterial hypertension, has continuously pushed boundaries over the past six years, securing patents in more than 40 countries and repeatedly showcasing its expertise in Pulmonary Artery Denervation (PADN) on the international stage! Stay true to yourself, remain faithful to your original aspiration! Walking with patients!
Pamu Medical, founded in 2013, specializes in the field of pulmonary hypertension. As the first Chinese company in this field to receive FDA Breakthrough Device designation, Pamu Medical’s independently developed PADN procedure has been featured multiple times on international stages in Europe, the United States, and Asia, where it has been used for theoretical instruction and surgical demonstrations. An increasing number of comparative studies are actively validating the efficacy and safety of PADN. In the future, PADN, as a therapeutic approach effective for multiple conditions associated with pulmonary hypertension, is poised to become a formidable adversary to PAH and a beacon of hope for patients. Its two major product categories—high-frequency ablation devices and intravascular catheters—are both international innovations, protected by several domestic and international invention patents.
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