Pulnovo Medical has enrolled the first two US patients in its PULSE-LHD clinical trial evaluating pulmonary artery denervation for pulmonary hypertension associated with left heart disease.

The procedures were performed at Henry Ford Hospital in Detroit under a US Food and Drug Administration Investigational Device Exemption.

The milestone marks the start of US clinical evaluation of Pulnovo’s pulmonary artery denervation approach in World Health Organization Group 2 pulmonary hypertension.

PULSE-LHD is a multicentre, randomised, placebo-procedure-controlled study designed to evaluate the safety and efficacy of pulmonary artery denervation in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease.

The trial is registered as NCT07214376.

Pulmonary hypertension associated with left heart disease is the most prevalent form of pulmonary hypertension and accounts for an estimated 65% to 80% of cases, according to Pulnovo.

Despite advances in treatment for underlying heart failure, the company said there is currently no therapy specifically approved for pulmonary hypertension associated with left heart disease.

Pulnovo’s investigational procedure uses the Enhancor System to perform percutaneous pulmonary artery denervation through radiofrequency ablation.

The treatment is being investigated alongside guideline-directed medical therapy.

Dr Waleed Al-Darzi, cardiologist at Henry Ford Health and site principal investigator, said enrolment of the first patients marks an important step in evaluating a new treatment strategy for this patient population.

The study received CMS Category B coverage approval in March 2026.

Pulnovo has also been developing its clinical evidence base for pulmonary artery denervation across other markets.

Data from the PADN-Columbus pilot study presented at EuroPCR 2026 reported initial safety findings and preliminary signals relating to pulmonary haemodynamics and functional capacity.

The company also plans to present results from its parallel PADN-HF-PH registration study in China at ESC Congress 2026.

Cynthia Chen, Chairlady and President of Pulnovo Medical, said the US study forms part of the company’s broader global clinical development programme across Asia, Europe and the United States.

The PULSE-LHD programme will provide additional evidence on whether pulmonary artery denervation can offer a device-based treatment option for patients with pulmonary hypertension linked to left heart disease.