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Pulnovo Medical's Latest Breakthrough in Pulmonary Hypertension Treatment

Pulnovo Medical, a globally recognized leader in medical devices targeting pulmonary hypertension and heart failure, has announced a significant advancement in its PADN (Pulmonary Artery Denervation) system. On September 13, 2025, the company revealed it has received two Investigational Device Exemption (IDE) approvals, paving the way for clinical trials in the United States.

The IDE approvals include one for an approved study focusing on Group I pulmonary hypertension patients and another for a PMA-approved study involving patients from Group II, signifying a milestone in the development of innovative treatments for these serious conditions. Importantly, this progress comes with full coverage by the Centers for Medicare & Medicaid Services (CMS), which aids in the accessibility and affordability of this cutting-edge therapy for patients.

The Significance of the IDE Approvals

The newly obtained IDE approvals will allow Pulnovo Medical to push forward with clinical studies in the United States that target these two critical patient groups. Group I pertains to patients suffering from pulmonary arterial hypertension (PAH), while Group II includes those with PAH due to left heart disease. The aim of these trials is to provide thorough validation of the PADN technology in its efficacy and safety for treating these conditions. This dual-focus approach is vital as it seeks to enhance treatment options available to patients struggling with pulmonary hypertension and heart failure.

Following the FDA's Breakthrough Device Designation granted in 2021 for Groups I, II, and IV, these IDE approvals are seen as a critical step forward. They not only highlight Pulnovo’s commitment to advancing patient care but also spotlight the pressing needs within the healthcare community to develop effective interventions for conditions that have limited treatment avenues.

A Global Perspective on PADN Technology

The PADN system has already made its mark outside the United States, having garnered approval in various countries, including China, where it is marked for use under the NMPA's regulations, and multiple European nations with CE marking. Pulnovo's technology has been employed in over 1,000 clinical applications globally, consistently demonstrating a solid safety profile and therapeutic efficacy in real-world settings.

With the PADN method particularly beneficial for patients with Group I PAH, where traditional medication responses may not be effective, there is a clear demand for innovative solutions that can address unmet clinical needs. Also, for patients in Group II with no specifically approved treatments, this technology could provide a crucial lifeline, significantly improving patient outcomes.

Future Implications and Expectations

The IDE approval marks a pivotal advance in Pulnovo Medical's ongoing mission to deliver high-quality and innovative solutions to patients with pulmonary hypertension. The results derived from these upcoming clinical studies are expected to yield valuable data that can further validate the PADN system's potential. Not only will the data reinforce the therapeutic capabilities of the PADN, but they will also offer crucial insights into how this advanced treatment can enhance daily life for patients through improved exercise tolerance and overall quality of life.

As Pulnovo Medical prepares to initiate these clinical trials, stakeholders in the medical field eagerly anticipate the findings that will emerge. The expansion of PADN technology and the ongoing commitment to high standards of safety and efficacy reinforce Pulnovo Medical’s dedication to improving healthcare outcomes for patients worldwide in critical need of better treatment options.