SHANGHAI, March 28, 2023 /PRNewswire/ -- Pulnovo Medical Limited, a globally recognized OTM platform, announced the results from its PADN series study during the Late-Breaking Clinical Science (LBCS) session of the second Technology and Heart Failure Therapeutics (THT 2023), with the presentation of its follow-up findings from PADN-5 study. As the first sham randomized controlled study to explore pulmonary artery denervation (PADN) in heart failure combined with CpcPH, PADN-5 achieved exciting and ground-breaking outcomes -- PADN showed great long-term effects over a 3-year follow-up period and consistently outperformed the control group.
The findings have proven to be of great interest to the global cardiovascular experts community. The study, which focuses on a world-class clinical challenge and is the first to demonstrate the long-term safety and efficacy of PADN in the treatment of heart failure combined with CpcPH, may offer new hope for the future of heart failure treatment worldwide.
At the international conference, Prof. Gregg W. Stone, one of the world's leading cardiovascular experts, spoke at a special morning session on PADN technology, bringing innovative medical device treatments back into the spotlight among global heart failure experts. The full support of international specialists in cardiovascular research demonstrated the unwavering potency of PADN technology across national boundaries. The PADN International Multicentre Clinical Trial will be available soon, which may provide new evidence for the clinical application of PADN and open new chapters in the global development of PADN technology.
About the 3-year Follow-up Results from PADN-5 Study
PADN-5 is a multi-center, randomized, sham-operated, controlled clinical trial designed to evaluate the efficacy and safety of PADN in the treatment of patients with CpcPH related to heart failure. The trial enrolled 98 patients with CpcPH related to left heart failure who met the inclusion criteria of being on a maximum tolerated dose of heart failure medications, achieving clinical stability, and being off PAH-targeting drugs for at least 3 months. 48 patients were in the treatment group (PADN + standard heart failure drug therapy) while 50 patients were in the control group (sham operation + Sildenafil + standard heart failure drug therapy).
The results of the study showed that the incidence of clinical deterioration at 6 months, 1 year and 3 years was significantly lower in the study group than in the control group, and the incidence of readmission due to heart failure, cardiac death, and all-cause mortality at 1 and 3 years after surgery was also significantly lower in the study group than in the control group. Other endpoints such as N-terminal pro b-type natriuretic peptide (NT-proBNP) and 6-minute walk distance (6MWD) were also considerably improved in the study group than in the control group at 6 months and 3 years post-operatively, as were pulmonary vascular resistance (PVR) and pulmonary capillary wedge pressure (PCWP) measured by right heart catheterization (RHC) at 6 months post-operatively.
The 3-year follow-up results of the PADN-5 study showed the long-term benefits of PADN for patients with CpcPH. In contrast to Sildenafil plus a standard drug therapy for heart failure, PADN plus a standard drug therapy for heart failure significantly reduced the incidence of clinical deterioration, whether at 6 months, 1 year or 3 years post-operatively. In addition, PADN was effective in improving hemodynamic parameters, increasing exercise tolerance among patients, and improving their cardiac function and clinical prognosis.
PADN is a ground-breaking and innovative PH treatment, ushering in a new era of device intervention for PH. Since the first human trial of PADN-1, PADN has been explored and validated in patients with PH, and has won the attention and recognition of the global academic community with the publication of exceptional data from PADN-1, PADN-1 Phase II, PADN-5 and PADN-CFDA. In August 2022, PADN was included for the first time in the updated edition of ESC/ERS Guidelines for the Diagnosis and Treatment of PH, bringing patients with PH worldwide new hope.
About Pulnovo Medical
Pulnovo Medical Limited, a Global OTM Innovative Platform, is a globally recognized device pioneer in the treatment for cardiopulmonary diseases. Established in 2013 and rooted in innovation, Pulnovo Medical upholds evidenced-based research and translational medicine, and starts our research and development efforts alongside physicians at the operating table with the goal to market our innovative therapeutic solutions and benefit patients around the world.
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