Salute e Benessere
Pulnovo Medical Receives two IDE approvals for PADN system's clinical trials with CMS coverage
PADN has received FDA HUD designation, is approved by the NMPA, and is CE-marked, meaning it meets high safety and efficacy standards globally. Pulmonary Artery Denervation (PADN) offers more options for both Group I pulmonary arterial hypertension patients with limited response to existing drug therapies and Group II pulmonary hypertension patients, who currently have no specifically approved treatment. With over 1,000 clinical applications across countries such as Portugal , Georgia , Singapore , Malaysia , and China , PADN products have consistently demonstrated a strong safety profile and therapeutic efficacy in real-world settings.
The approval marks a critical step in Pulnovo Medical's commitment to delivering innovative, high-quality solutions for patients with pulmonary hypertension and accelerating the global expansion of PADN technology. The results of these studies will generate valuable data to further validate the potential of PADN. Progress in these clinical trials is expected to bring meaningful benefits to patients, including improved exercise tolerance in daily life and a better overall quality of life.
View original content:https://www.prnewswire.com/news-releases/pulnovo-medical-receives-two-ide-approvals-for-padn-systems-clinical-trials-with-cms-coverage-302555008.html