Pulnovo Medical Enrolls First U.S. Patients in PULSE-LHD IDE Trial of PADN for Pulmonary Hypertension Associated with Left Heart Disease
核心洞察
Pulnovo Medical (搜索) enrolled the first two patients in its PULSE-LHD IDE clinical trial at Henry Ford Hospital (搜索) in Detroit, marking the U.S. initiation of the PADN procedure study.
The randomized, placebo-procedure controlled trial (NCT07214376) evaluates Pulmonary Artery Denervation in patients with combined pre- and post-capillary pulmonary hypertension (搜索) associated with left heart disease (CpcPH-LHD).
PH-LHD accounts for 65% to 80% of all pulmonary hypertension (搜索) cases, yet no therapy is currently approved for its treatment, underscoring a significant unmet clinical need.
Pulnovo Medical (搜索), a globally recognized pioneer in medical devices for pulmonary hypertension (搜索) (PH) and heart failure (搜索) (HF), has enrolled the first two patients in its PULSE-LHD clinical trial, conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) at Henry Ford Hospital (搜索) in Detroit. Working in close collaboration with Site Principal Investigator Dr. Waleed Al-Darzi, Dr. Vikas Aggarwal and Dr. Brian O'Neill successfully performed the procedures for these initial patients. The milestone marks the initiation of the IDE study and represents a major step forward in the clinical advancement of the Pulmonary Artery Denervation (PADN) (搜索) procedure.
By specifically targeting World Health Organization (WHO) Group 2 Pulmonary Hypertension (搜索), this IDE trial is designed to generate broader clinical data and expand the potential reach of this innovative therapy to a significantly larger patient population.
Trial Design and Objectives
The study (NCT07214376) is a multi-center, randomized, placebo-procedure controlled trial designed to evaluate the safety and efficacy of Pulmonary Artery Denervation (PADN) (搜索) in patients with combined pre- and post-capillary pulmonary hypertension (搜索) associated with left heart disease (CpcPH-LHD). As the most prevalent subtype of pulmonary hypertension, PH-LHD accounts for 65% to 80% of all cases. Despite advances in heart failure (搜索) management, patients with PH-LHD continue to experience substantial morbidity.
There is currently no therapy approved for the treatment of PH-LHD, creating an urgent demand for innovative therapeutic strategies. Furthermore, the PULSE-LHD IDE study (G250159) received CMS Category B coverage approval on March 24, 2026.
Clinical Significance and Unmet Need
"The enrollment of the first patients in the PULSE-LHD trial is an exciting step toward evaluating a novel treatment strategy for pulmonary hypertension (搜索) associated with left heart disease," said Dr. Waleed Al-Darzi, a Henry Ford Health cardiologist and the site principal investigator at Henry Ford Hospital (搜索). "This condition affects a large number of patients and remains an area of significant unmet clinical need. We are proud to help lead this important research and look forward to generating evidence that may inform future treatment options for patients."
Jessie Lian, Executive Director and CEO of Pulnovo Medical (搜索), said: "Bringing innovative technologies to the global stage requires a deep understanding of local clinical practices and a commitment to tackling implementation challenges head-on. Achieving this milestone alongside our frontline teams perfectly exemplifies our exceptional execution in multi-center collaboration. Advancing the PULSE-LHD trial to the highest quality standards in partnership with top-tier institutions like Henry Ford Hospital (搜索) is key to building our robust clinical evidence base."
Global Strategy and Evidence Base
"The initiation of the PULSE-LHD trial is a pivotal moment in our overarching global strategy," said Cynthia Chen, Chairlady and President of Pulnovo Medical (搜索). "Our focus extends far beyond a single clinical trial; we are building a worldwide clinical foundation focused on generating the evidence needed to determine whether PADN can become a standard of care for cardiopulmonary diseases."
The clinical evidence base for PADN in treating PH-LHD has been building rapidly this year. In May, data from the PADN-Columbus pilot study presented at EuroPCR 2026 demonstrated the procedure's initial safety and preliminary signals of benefit in pulmonary hemodynamics and functional capacity. Building on these promising early results, Pulnovo Medical (搜索) will officially present data from the parallel PADN-HF-PH registration trial in China at the upcoming ESC Congress 2026.
About the PADN Procedure
Pulnovo's proprietary Pulmonary Artery Denervation (PADN) (搜索) is a minimally invasive therapy designed to modulate overactivated sympathetic nerve activity that contributes to pulmonary vascular remodeling and cardiopulmonary disease progression. In studies conducted outside the United States, primarily in WHO Group 1 PH, PADN has been associated with improvements in functional capacity and lower rates of clinical worsening. These results have not been established in PH-LHD and are not predictive of PULSE-LHD outcomes.
The therapy is included as an investigational interventional therapy in the 2022 ESC/ERS guidelines, which identify its clinical benefit as a gap in evidence. Building upon its regulatory approvals in 12 countries/regions and clinical experience of approximately 1,500 procedures in WHO Group 1 PH, Pulnovo Medical (搜索) is expanding its clinical investigation of the therapy into WHO Group 2 PH associated with Left Heart Disease (PH-LHD) to address the significant unmet clinical needs of this broader patient population.
The Pulnovo Multi-Pole Pulmonary Artery Radiofrequency Ablation Enhancor™ System (搜索) is an investigational device that has not been approved or cleared by the U.S. Food and Drug Administration (FDA) for the treatment of pulmonary hypertension (搜索) associated with left heart disease (PH-LHD). Its safety and effectiveness for this use have not been established, and it is not available for commercial sale in the United States.