Pulnovo Medical begins US trial of pulmonary artery denervation

Pulnovo Medical has initiated its PULSE-LHD clinical trial in the United States with the enrollment of two initial patients. The study will assess the efficacy and safety of pulmonary artery denervation (PADN) in treating pulmonary hypertension associated with left heart disease (PH-LHD).

Pulmonary hypertension linked to left heart disease is a serious condition that can lead to life-threatening complications. The PADN procedure involves the surgical removal of nerves that regulate the function of pulmonary arteries. Pulnovo Medical's technology aims to improve patient quality of life and reduce hospitalizations.

The IDE (Investigational Device Exemption) study, approved by the U.S. Food and Drug Administration (FDA), marks a significant step towards a novel treatment. The research is expected to yield critical data on PADN's potential to address PH-LHD, a condition with currently limited therapeutic options.

Pulnovo Medical anticipates that the trial's outcomes could support broader application of the PADN procedure in the future. The company has previously reported positive findings from similar trials conducted in Europe.