The study, conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption, seeks to address a significant gap in cardiovascular care. While pulmonary hypertension linked to left heart disease accounts for up to 80% of all pulmonary hypertension cases, no specific therapies are currently approved for this condition. The trial is a multi-center, randomized, placebo-procedure controlled study designed to evaluate the safety and efficacy of the PADN procedure in patients with combined pre- and post-capillary pulmonary hypertension.

Dr. Waleed Al-Darzi, the site principal investigator at Henry Ford Hospital, led the initial procedures alongside Dr. Vikas Aggarwal and Dr. Brian O'Neill. This development follows recent global momentum for the technology, including pilot study data presented at EuroPCR 2026 and upcoming results from a registration trial in China set for the ESC Congress 2026. The PULSE-LHD study has also secured CMS Category B coverage approval, clearing a path for the research to proceed as the company aims to determine if PADN can establish itself as a standard of care for cardiopulmonary diseases.