Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), announced the enrollment of the first two patients in its PULSE-LHD clinical trial, conducted under a U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE), at Henry Ford Hospital in Detroit. Working in close collaboration with Site Principal Investigator Dr. Waleed Al-Darzi, Dr. Vikas Aggarwal and Dr. Brian O'Neill successfully performed the procedures for these initial patients. The milestone marks the initiation of the IDE study, representing a major step forward in the clinical advancement of the PADN procedure. By specifically targeting World Health Organization (WHO) Group 2 Pulmonary Hypertension, this 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 (NCT07214376) is a multi-center, randomized, placebo-procedure-controlled trial designed to evaluate the safety and efficacy of Pulmonary Artery Denervation (PADN) in patients with combined pre- and post-capillary pulmonary hypertension associated with left heart disease (CpcPH-LHD). As the most prevalent subtype of pulmonary hypertension, PH-LHD accounts for 65 per cent to 80 per cent of all cases. Despite advances in heart failure management, patients with PH-LHD continue to experience substantial morbidity. There is currently no therapy approved for the treatment of PH-LHD, creating an urgent demand for innovative therapeutic strategies. Furthermore, the PULSE-LHD IDE study (G250159) received CMS Category B coverage approval on March 24, 2026.
"The enrollment of the first patients in the PULSE-LHD trial is an exciting step toward evaluating a novel treatment strategy for pulmonary hypertension associated with left heart disease," said Dr. Waleed Al-Darzi, a Henry Ford Health cardiologist and the site principal investigator at Henry Ford Hospital. "This condition affects a large number of patients and remains an area of significant unmet clinical need. We are proud to help lead this important research and look forward to generating evidence that may inform future treatment options for patients."
Jessie Lian, Executive Director and CEO of Pulnovo Medical, said: "Bringing innovative technologies to the global stage requires a deep understanding of local clinical practices and a commitment to tackling implementation challenges head-on. Achieving this milestone alongside our frontline teams perfectly exemplifies our exceptional execution in multi-center collaboration. Advancing the PULSE-LHD trial to the highest quality standards in partnership with top-tier institutions like Henry Ford Hospital is key to building our robust clinical evidence base. We will continue to accelerate the advancement of the PADN procedure, dedicated not only to addressing the immense unmet clinical needs in Group 2 pulmonary hypertension, but also to bringing renewed hope for health to a broader population of heart failure and pulmonary hypertension patients worldwide."
