Medical technology company Pulnovo Medical announced on Sunday the enrolment of the first two patients in its PULSE-LHD clinical trial, conducted under a US Food and Drug Administration (FDA) Investigational Device Exemption (IDE), at Henry Ford Hospital in Detroit.

This marks the initiation of the IDE study, representing a major step forward in the clinical advancement of the Pulmonary Artery Denervation (PADN) procedure. By specifically targeting World Health Organization (WHO) Group 2 Pulmonary Hypertension, the IDE trial is designed to generate broader clinical data and expand the potential reach of this innovative therapy to a significantly larger patient population.

The study is a multi-centre, randomised, placebo-procedure controlled trial 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). According to the company, there is currently no therapy approved for the treatment of PH-LHD, creating an urgent demand for innovative therapeutic strategies.

Pulnovo Medical will present data from the parallel PADN-HF-PH registration trial in China at the upcoming ESC Congress 2026.