Pulnovo Medical has enrolled the first two US patients in its PULSE-LHD clinical trial, evaluating pulmonary artery denervation (PADN) for pulmonary hypertension associated with left heart disease.
The PULSE-LHD trial is being conducted under a US Food and Drug Administration (FDA) investigational device exemption (IDE) at Henry Ford Hospital in Detroit.
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Drs Vikas Aggarwal and Brian O’Neill performed the initial procedures with site principal investigator Dr Waleed Al-Darzi.
This marks the initiation of the PULSE-LHD IDE study, which aims to generate broader clinical data on PADN in World Health Organization (WHO) Group 2 pulmonary hypertension.
The trial is a multi-centre, randomised, placebo-procedure controlled study. It is designed to evaluate the safety and efficacy of PADN in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease (CpcPH-LHD).
Pulnovo Medical executive director and CEO Jessie Lian 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-centre collaboration.
“Advancing the PULSE-LHD trial to the highest quality standards in partnership with top-tier institutions like Henry Ford Hospital is key to building our robust clinical evidence base.
“We will continue to accelerate the advancement of the PADN procedure, dedicated not only to addressing the immense unmet clinical needs in Group 2 pulmonary hypertension, but also to bringing renewed hope for health to a broader population of heart failure and pulmonary hypertension patients worldwide.”
Pulnovo Medical’s PADN is a minimally invasive therapy designed to modulate sympathetic nerve activity involved in pulmonary vascular remodelling and disease progression.
Studies outside the US, primarily in WHO Group 1 PH, have shown associations with improvements in functional capacity and clinical outcomes, though these results have not been established for PH-LHD and are not predictive of PULSE-LHD outcomes.
PADN is listed as an investigational therapy in the 2022 ESC/ERS guidelines, which highlight a gap in evidence for this approach.
Data from the PADN-Columbus pilot study, presented at EuroPCR 2026, showed initial safety findings and early signals of benefit in pulmonary haemodynamics and functional capacity. Furthermore, data from the PADN-HF-PH registration trial in China is expected to be presented at the upcoming ESC Congress 2026.
Pulnovo Medical has secured regulatory approvals for its PADN system in 12 countries and regions for WHO Group 1 PH.
The PADN multi-pole pulmonary artery RF ablation catheter and generator have recently received approvals in Indonesia, Malaysia, and the Baltic States. The company claimed to have conducted around 1,500 PADN procedures outside the US and is expanding its clinical investigation to WHO Group 2 PH associated with left heart disease.
In April 2026, Pulnovo Medical completed a $100m strategic financing round led by Medtronic, with participation from existing and new investors.
