Use of PADN device lowers risk of clinical worsening with PAH
Device aims to slow progression by targeting nerves around pulmonary artery
Treatment with Pulnovo Medical’s pulmonary artery denervation (PADN) device significantly reduced the risk of clinical worsening among people with pulmonary arterial hypertension (PAH) in a clinical trial, according to new data announced by the company.
Chen Shaoliang, a professor at Nanjing First Hospital of Nanjing Medical University in China, presented the findings at the recent American Cardiovascular Research Technologies conference (CRT 2023), according to a company press release.
PAH is characterized by abnormally high pressure in the blood vessels of the lungs. PADN is a treatment strategy that destroys the nerves around the pulmonary artery, the main vessel that carries blood from the heart to the lungs. In destroying these nerves, the procedure aims to lower pressure in the lung’s blood vessels, thereby slowing disease progression.
Risk of PAH worsening 5 times lower in trial patients given PADN procedure
Pulnovo’s device consists of a special looped catheter that is inserted through a large vein in the leg and uses radio waves to target nerves around the pulmonary artery.
A clinical trial called PADN-CFDA (NCT03282266), sponsored by Nanjing Medical University, tested the device in 128 adults, ages 18-70, with PAH. Patients underwent either PADN or a sham (pretend) procedure, where a catheter was inserted but radio waves were not applied to the nerves around the pulmonary artery. All were clinically stable and also were treated with a phosphodiesterase-5 inhibitor, which includes Revatio (sildenafil) or Adcirca (tadalafil).
The study’s main goal was to assess the effect of treatment on the distance participants could walk in six minutes, referred to as the 6MWD test, a common measure of exercise capacity. On average, patients given the PADN procedure showed improvement in the 6MWD at six months and one year following treatment, while sham procedure patients tended to worsen, results showed. By one year, the average difference between the two groups in the test was about 81 meters (265 feet).
Trial result also showed that the risk of clinical worsening was more than five times lower among patients given the PADN procedure compared to the sham. Rates of worsening PAH, disease-related hospitalizations, and needs for additional treatment also were significantly lower in the PADN group, Pulnovo reported.
At CRT 2023, Chen also presented a review of data from this and other trials testing the PADN procedure in various forms of pulmonary hypertension. Results broadly show that the procedure can lead to improvements in exercise capacity, blood flow dynamics, and clinical outcomes, according to Chen.