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Pulnovo Medical's Milestone Achievement in Clinical Research

Pulnovo Medical, a globally recognized leader in medical devices focused on pulmonary hypertension (PH) and heart failure (HF), has proudly announced a significant achievement in the form of two Investigational Device Exemption (IDE) approvals. These approvals pertain to the clinical trials of their PADN system with comprehensive coverage from the Centers for Medicare & Medicaid Services (CMS). This development is set to pave the way for upcoming clinical studies within the United States, marking a pivotal moment in the treatment of pulmonary diseases.

In 2021, Pulnovo Medical was granted Breakthrough Device Designation (BDD) status from the FDA for their systems addressing Groups I, II, and IV of PH. The new IDE approvals further advance this status, enabling clinical studies for Groups I and II to commence the IDE phase. The primary focus of these studies will be to evaluate the effectiveness and safety of the PADN technology for diverse patient demographics, specifically targeting Group I (pulmonary arterial hypertension, PAH) and Group II (PH related to left heart disease).

Both clinical trials are crucial as they will assist in verifying the application of PADN in various populations affected by pulmonary hypertension and heart failure. The benefits of these IDE approvals are multifaceted; they not only advance clinical application but also boost the market acceptance and reliance on PADN technology, with significant implications for patients across the region.

The PADN device has been classified as a Humanitarian Use Device (HUD) by the FDA, has received approval from the NMPA, and boasts a CE marking. This indicates that it meets stringent international standards for safety and efficacy. The pulmonary artery denervation (PADN) technology presents expanded possibilities for patients experiencing Group I pulmonary arterial hypertension who are resistant to conventional medication, alongside those in Group II who currently lack approved treatment options. With over 1,000 clinical applications already performed in countries like Portugal, Georgia, Singapore, Malaysia, and China, PADN products have consistently demonstrated a robust safety profile and therapeutic efficacy.

The IDE approval is a vital stride forward for Pulnovo Medical's commitment to delivering innovative and high-quality solutions to patients grappling with pulmonary hypertension. The ongoing studies will yield valuable data, further substantiating the potential of PADN technology and helping illuminate its future in clinical practice. From these advancements, substantial improvements in patient outcomes are anticipated, including enhanced exercise tolerance and a better overall quality of life.

By taking significant steps in the clinical research process, Pulnovo Medical is dedicated to ensuring that those suffering from debilitating heart and lung conditions have access to state-of-the-art healthcare solutions. The progression of these clinical trials is expected to not only foster a deeper understanding of PADN technology but also to significantly contribute to the global dialogue on best practices in treating pulmonary hypertension and associated heart issues. The excitement surrounding these developments underscores a promising future for patients and health care providers alike, aiming for better management and outcomes in the field of pulmonary health.