Pulnovo Medical, a medical technology company based in China, has enrolled the first two US patients in its PULSE-LHD clinical trial, marking the formal launch of a US FDA investigational device exemption (IDE) study.

The study evaluated pulmonary artery denervation (PADN) in patients with pulmonary hypertension associated with left heart disease.

The procedures were performed at Henry Ford Hospital in Detroit by Dr Vikas Aggarwal and Dr Brian O’Neill, with Dr Waleed Al-Darzi serving as the site principal investigator.

PULSE-LHD is a multicentre, randomized, placebo-procedure controlled study designed to assess the safety and efficacy of PADN in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease (CpcPH-LHD), classified as WHO Group 2 pulmonary hypertension.

The trial is intended to generate clinical evidence for PADN in a patient population where treatment options remain limited. Pulnovo said the US enrollment represents an important step in expanding the clinical evaluation of the technology beyond its earlier use primarily in WHO Group 1 pulmonary hypertension.

Pulnovo's PADN system is a minimally invasive technology that uses a multi-pole radiofrequency ablation catheterto modulate sympathetic nerve activity associated with pulmonary vascular remodeling and disease progression.

The company has conducted approximately 1,500 PADN procedures outside the US and has obtained regulatory approvals for the technology in 12 countries and regions for WHO Group 1 pulmonary hypertension.

Pulnovo noted that clinical studies conducted outside the US have reported associations between PADN and improvements in pulmonary hemodynamics, functional capacity and other clinical measures. 

However, the company stressed that these findings have not been established in pulmonary hypertension associated with left heart disease and should not be considered predictive of the PULSE-LHD trial outcomes.

PADN remains an investigational therapy, with the 2022 ESC/ERS pulmonary hypertension guidelines noting the limited clinical evidence supporting the approach.

Jessie Lian, executive director and CEO of Pulnovo Medical, said the US trial milestone demonstrates the company's ability to execute complex multicentre clinical studies and work with frontline clinical teams.