Perhaps most people rarely hear about pulmonary hypertension (PH) disease. PH is a group of pathophysiological syndromes characterized by increased pulmonary artery pressure (≥25mmHg at rest) and pulmonary vascular resistance (≥2.5Woodunits at rest) caused by different etiologies, which eventually lead to the right heart increased load, right heart failure and, potentially, sudden death.

PH, the "cancer of the heart and lung vascular system", has a very high incidence and fatality rate. However, because of limited knowledge about the disease, it is ignored by many medical practitioners and the public alike. The White paper on Survival Status of Chinese Patients with Pulmonary Hypertension shows that it takes on average 2.6 years for a patient to receive treatment after they are diagnosed with PH. 

The existing treatments for PH mainly rely on targeted drugs and lung transplantation, with drug treatment costs very high. As for lung transplantation, due to the limited availability of organs and the common complications of infection and rejection in postoperative patients, this treatment faces significant complexities. 

In order to tackle these challenges, a Chinese company Pulnovo Medical has designed a new treatment method called pulmonary artery denervation (PADN), which 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.

To be specific, after connecting with a radiofrequency ablation instrument, it damages the serous membrane through the intima of the pulmonary artery. When the sympathetic nerve of the proximal pulmonary artery is ablated, pulmonary artery pressure drops.

The research results of "Pulmonary Artery Denervation: The New Kid on the Block?" is published in the Editorial Comment of JACC Vol. 76, No. 8, 2020, showing that PADN has a better surgical effect and a lower price than current drug treatments.

Moreover, Pulnovo has developed medical devices for use in the treatment of PH. "The PADN device cooperates with the catheter to achieve the purpose of treating PH by ablating the sympathetic nerve of the pulmonary artery," Cynthia Chen, Pulnovo's executive director said. 

The shape of Pulnovo's device is more in line with the inner wall of the pulmonary artery, which greatly improves the safety and efficiency of the radiofrequency ablation, and significantly reduces the surgical procedure time. More importantly, this product pioneered the multi-electrode ring tip model to achieve point-to-point ablation of pulmonary sympathetic nerves.

"At the beginning of 2021, Pulnovo received a FDA breakthrough designation, being the first Chinese medical device company in PH field to receive such certification," Chen said, "This year, Pulnovo has completed all the PADN-CFDA (China-FDA) clinical trial patients' enrollment and follow up, and we will continue to work with the National Research Center to complete the rest of the work."

The PADN-CFDA clinical trial is the world's first randomized, controlled study to evaluate a PH treatment device, according to Pulnovo.

Chen said "the road of global medical innovation has never been an easy journey. Because our technology is new and the disease penetration is low, the difficulties faced in the promotion stage of clinical trials are everywhere. However, we have concentrated on the research and overcome the problems, just as our motto reflects, In Pulnovo, We Speak Science."

According to Pulnovo, PADN has marked the new era in the treatment of PH, and the global industrial structure of PH is undergoing rapid transformation. In the era of globalization, Pulnovo has entered the world stage as a Chinese pioneer in the industry.

However, there are still potential patients and even healthcare professionals who do not fully understand the disease, and who would benefit from learning more about PADN. 

Thus, Pulnovo will enable more training and education as it relates to PH knowledge and PADN surgery, establish clinical education demonstration bases across China and strengthen cooperation with academic communities. Additionally, Pulnovo will over time carry out global multi-center clinical trials.