#Shanghai #United States #CMS #Pulnovo Medical #IDE Approvals

Pulnovo Medical Receives IDE Approvals

On September 12, 2025, Pulnovo Medical, a globally recognized leader in medical devices for pulmonary hypertension (PH) and heart failure (HF), proudly announced it has received two Investigational Device Exemption (IDE) approvals from the FDA for its innovative PADN system. This authorization paves the way for significant clinical trials in the United States, guaranteeing comprehensive coverage from the Centers for Medicare & Medicaid Services (CMS).

Background of the PADN System

Pulnovo Medical's PADN system has been developed to address the pressing need for effective treatments for patients suffering from PH, particularly Group I (Pulmonary Arterial Hypertension) and Group II (PH due to left heart disease). The system employs advanced technology to deliver a state-of-the-art treatment option that has already garnered multiple recognitions, including the designation of Humanitarian Use Device (HUD) by the FDA, as well as approvals from the National Medical Products Administration (NMPA) and CE marking.

The device has shown exemplary results in over 1,000 clinical applications across various countries, including Portugal, Georgia, Singapore, Malaysia, and China. The feedback from these applications demonstrates an impressive safety profile and therapeutic efficacy, reinforcing the device’s potential to improve the lives of patients worldwide.

Significance of the Ide Approvals

The FDA granted BDD (Breakthrough Device Designation) to Pulnovo Medical in 2021 for Groups I, II, and IV. The newly secured IDE approvals allow clinical studies targeting Groups I and II to progress to the IDE phase—critical for validating the PADN system's effectiveness in treating pulmonary hypertension and heart failure. These trials aim to compile robust data demonstrating the benefits of PADN, focusing on patient outcomes such as exercise tolerance and quality of life improvements.

The ability to conduct clinical trials under IDE not only indicates the device's innovative capacity but also underscores the growing acceptance of PADN technology in the market. With CMS coverage, these trials can potentially lead to widespread acceptance and utilization of the PADN system, enhancing the treatment landscape for patients suffering from challenging heart and lung conditions.

Path Forward for Pulnovo Medical

The commitment of Pulnovo Medical to providing high-quality, innovative solutions for those affected by pulmonary hypertension is evident in its continual efforts to push the boundaries of medical technology. The approval of these IDEs represents a pivotal step in expanding clinical capabilities and enhancing therapeutic options for patients in the United States.

As the clinical trials commence, the data generated will be critical in validating PADN's potential, with expectations that it will significantly contribute to clinical practices and patient benefits, redefining treatment protocols for PH and heart failure.

This progress aligns with Pulnovo Medical's vision of improving healthcare outcomes globally, reinforcing its position as a leader in medical device innovation tailored for challenging health conditions. With its ongoing developments, Pulnovo Medical is poised to make a lasting impact on the treatment of pulmonary hypertension and heart failure, leading to enhanced patient care and improved quality of life.