Pulnovo Medical Completes Enrollment in Trial of Pulmonary Artery Denervation to Treat Hypertension

June 28, 2021—Pulnovo Medical announced that the PADN-CFDA randomized controlled trial of the company’s pulmonary artery denervation (PADN) device to treat hypertension has completed patient enrollment.

The company, which is based in Nanjing, China, advised it will continue to assist each enrollment center to complete the follow-up of enrolled patients, data recovery, data cleaning, and other matters. Additionally, it will cooperate with China’s research center to complete follow-up work.

In the United States, Pulnovo Medical’s radiofrequency ablation product was granted FDA Breakthrough designation in 2021.

The company explained that percutaneous PADN is an interventional ablation technique that punctures the patient’s femoral vein and sends a special looped catheter to the proximal end of the pulmonary artery bifurcation. After connecting with a radiofrequency ablation instrument, it damages the serous membrane through the intima of the pulmonary artery.

The company stated that when the sympathetic nerve of the proximal pulmonary artery is ablated, the pulmonary artery pressure drops.

An evaluation of PADN in patients with residual pulmonary hypertension after pulmonary endarterectmony was published last year by Alexander Romanov, MD, et al in Journal of the American College of Cardiology (2020;76:916-926).

According to the company, the clinical data showed that percutaneous PADN significantly improved the 6-minute walk test distance of polytype pulmonary hypertension. Mean pulmonary artery pressure and pulmonary vascular resistance were significantly reduced without related complications. In addition, percutaneous PADN also has a therapeutic effect on mixed pre- and postcapillary pulmonary hypertension secondary to left heart failure.

In an accompanying editorial, “Pulmonary Artery Denervation: The New Kid on the Block?”, Marius M. Hoeper, MD, discussed the mechanism of action of PADN, the findings of Romanov et al, and the developing evidence regarding this treatment (2020;76:927-929). Dr. Hoeper noted that Romanov et al showed PADN has a better surgical effect and a lower price than drug treatment, stated Pulnovo.