Pulnovo’s PADN Devices Approved in China and Receive FDA Humanitarian Use Designation

January 2, 2024—Pulnovo Medical Limited recently announced that it has received approval from China’s National Medical Products Administration for the company’s pulmonary artery denervation (PADN) catheter and generator. The PADN devices are used for interventional radiofrequency (RF) ablation in the treatment of pulmonary arterial hypertension (PAH). Pulnovo is based in Nanjing, China.

In the United States, the company obtained humanitarian use device designation from the FDA for the PADN catheter and generator. Also, the United States Medicare & Medicaid Services approved a Medicare coverage code for the devices. The PADN devices recently have been endorsed by the American Medical Association, noted the company.

In 2021, Pulnovo’s PADN technology received FDA Breakthrough Device designation. In August 2022, PADN was included for the first time in the international European Society of Cardiology guidelines, which affirmed the improvement of clinical outcomes of PAH patients after PADN, stated Pulnovo.

According to the company, the Pulnovo PADN system consists of a multipole pulmonary artery RF ablation catheter and a multipole pulmonary artery RF ablation generator. PADN uses RF ablation to block pulmonary intima sympathetic nerves and reduce pulmonary artery pressure to delay disease progression.

The company has conducted the PADN-1 phase 1, PADN-1 phase 2, PADN-5, and other studies composed of more than 400 patients to provide evidence for the safety and efficacy of PADN.

In September 2022, results were reported from a sham-controlled clinical evaluation of PADN for patients with PAH using Pulnovo’s catheters that was conducted in China. The study found that PADN increased exercise capacity and improved hemodynamics and clinical outcomes during 6-month follow-up.

The findings were presented at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium held in Boston, Massachusetts, and published by Hang Zhang, MD, et al in JACC: Cardiovascular Interventions (2022;15:2412–2423).