Pulnovo Medical Secures FDA Breakthrough Device Designation for Novel PADN Catheter in Pulmonary Hypertension Treatment

Recently,Pulnovo Medical Limited(English Name:Pulnovo Medical；Abbreviated as Pulnovo Medical) independently developed for the treatment of pulmonary arterial hypertensionMultipolar Synchronous Pulmonary Artery Radiofrequency Ablation Catheter Receives U.S.FDABreakthrough Medical Device Designation。

Pulnovo Medical stated: “The entire process from application to approval for this project took only 16 days, setting a new record for the shortest approval time for a Chinese domestic enterprise. This designation not only signifies the FDA’s high recognition of Pulnovo Medical’s proprietary technology for the multipolar synchronized radiofrequency ablation catheter for pulmonary arteries, but will also greatly accelerate the development and review processes for pre-market clinical studies of this product in the United States. Once approved, the device will be immediately eligible for coverage under U.S. health insurance programs, facilitating large-scale clinical adoption.”

Data shows that,This accreditation is the first of its kind in the field of pulmonary hypertension treatment in China.。

Pulnovo Medical, established in 2013, specializes in the field of pulmonary hypertension. Its two flagship product lines—high-frequency ablation devices and intravascular catheters—are both international firsts, backed by several domestic and international invention patents. Currently, Pulnovo Medical has constructed Class 10,000 cleanrooms, active production workshops, and warehouses in compliance with GMP and ISO 13485 standards. The company boasts comprehensive water-for-injection and purified water systems, as well as independent physical, chemical, and microbiological laboratories, equipped with a full range of professional testing instruments and production facilities.

Professor Chen Shaoliang, founder of Pulnovo Medical, is a leading cardiovascular expert in China. He has achieved over 40 scientific and technological research outcomes, organized more than 10 international, prospective, multicenter clinical studies, and holds 15 patents for inventions and utility models.In 2012, Professor Chen Shaoliang pioneered percutaneous pulmonary artery denervation (PADN) and collaborated with engineers to develop medical devices specifically designed for use in this procedure.High-frequency ablation device and intravascular catheter.

Pulmonary hypertension refers to a clinical and pathophysiological syndrome characterized by structural or functional changes in the pulmonary vasculature, resulting from various heterogeneous diseases (etiologies) and different pathogenic mechanisms, which lead to increased pulmonary vascular resistance and elevated pulmonary arterial pressure.Subsequently progressing to right heart failure and even death. Currently, there is no cure for this disease. Pharmacological treatments for pulmonary hypertension are expensive and associated with poor prognosis, while non-pharmacological interventions, such as atrial septostomy or lung transplantation, face significant challenges including high mortality rates and donor shortages.Percutaneous pulmonary artery denervation has demonstrated its safety and efficacy through animal studies, human trials, and before-and-after controlled clinical trials, providing a novel therapeutic option for numerous patients with pulmonary hypertension.

Percutaneous Pulmonary Artery Denervation is an interventional ablation technique. This procedure involves puncturing the patient's femoral vein to advance a specialized circular catheter to the proximal segment of the pulmonary artery bifurcation. Upon connection to a radiofrequency ablation generator, the device induces endoluminal injury to the pulmonary artery, thereby ablating the subadventitial sympathetic nerves. Ablation of the proximal pulmonary artery sympathetic nerves results in a reduction of pulmonary artery pressure.

Professor Chen Shaoliang, the inventor of percutaneous pulmonary artery denervation, has repeatedly presented relevant clinical research findings at the Transcatheter Cardiovascular Therapeutics (TCT) conference in the United States, confirming its excellent safety and efficacy. To date, Professor Chen has traveled extensively to Europe, the United States, and Asia for theoretical teaching and surgical demonstrations, provided live surgical guidance overseas on four occasions, and delivered more than 20 invited international academic lectures, attracting significant attention worldwide.

Clinical data indicate that percutaneous pulmonary artery denervation significantly improves the 6-minute walk distance in patients with various types of pulmonary hypertension, markedly reduces mean pulmonary arterial pressure and pulmonary vascular resistance, and is not associated with related complications. Furthermore, percutaneous pulmonary artery denervation demonstrates therapeutic efficacy for mixed pre- and post-capillary pulmonary hypertension secondary to left heart failure.

Pulnovo Medical, leveraging its expertise in percutaneous pulmonary artery denervation and radiofrequency ablation technologies, is committed to independent innovation and has secured multiple national invention patents as well as PCT international patents in Japan, Russia, South Korea, Singapore, and the European Union.

Pulnovo Medical stated: “The multipolar synchronous pulmonary artery radiofrequency ablation catheter, which has recently received FDA Breakthrough Device designation, achieves the treatment of pulmonary hypertension by ablating sympathetic nerves at target sites. This product pioneers a ‘multi-electrode circular tip’ design to enable ‘point-to-point’ ablation of pulmonary artery sympathetic nerves.”

Pulnovo Medical’s innovatively designed ring-shaped tip better conforms to the contour of the pulmonary artery wall, facilitating rapid electrode apposition. The tip remains stable against blood flow, preventing directional shifts and avoiding ineffective ablation. Additionally, Pulnovo Medical has developed circular and oval tips tailored to vascular anatomy, pre-loaded with 6 or 10 electrodes to enable point-to-point ablation. This design enhances ablation efficiency, reduces procedure time, and improves safety.

According to the final guidance issued by the FDA in December 2018 for the Breakthrough Devices Program, “Breakthrough Devices” and the accompanying Breakthrough Devices Program are designed to accelerate the development, evaluation, and review processes for innovative products, enabling earlier patient access to these technologies.

To qualify for the Breakthrough Devices Program, a medical device must meet two key criteria:

(1) The device facilitates more effective treatment or diagnosis of life-threatening or debilitating diseases or conditions.

(2) The device represents a breakthrough technology, with no approved alternative products currently available on the U.S. market;This device offers significant advantages over existing alternative devices., and the availability of this device is critical to the best interests of patients.

In accordance with FDA guidance, Breakthrough Devices will benefit from earlier communication, enhanced engagement pathways, and optimized review resources provided by the FDA to applicants during both the device research and development phase and the premarket review phase, building upon the Priority Review and Fast Track pathways.By implementing a regulatory framework that covers the entire market lifecycle, we aim to accelerate the market entry and widespread adoption of innovative products with significant clinical value.

After being designated as a Breakthrough Device, manufacturers may engage in face-to-face communications with staff from the FDA’s Center for Devices and Radiological Health (CDRH) or committee experts during key stages of device development, while maintaining records of such interactions. Through sprint meetings, manufacturers and the review team can establish a timeline and reach final consensus on specific issues within a stipulated period (45 days). Leveraging data development plans, manufacturers and the review team allocate pre- and post-market clinical data, thereby strengthening lifecycle regulation of such medical devices.

Meanwhile, to accelerate device market entry, the FDA balances premarket and postmarket data requirements by employing intermediate or surrogate clinical endpoints, converting certain premarket production inspections into postmarket inspections, and incorporating some postmarket requirements as conditions for conditional approval. Given the substantial value associated with regulatory clearance, the number of applicants continues to rise, leading to increasingly stringent review standards; thus, obtaining FDA approval is highly competitive and difficult.

Through years of accumulation and dedication in the field of pulmonary hypertension, Professor Chen Shaoliang’s invention of percutaneous pulmonary artery denervation now boasts over 42 global patents. After receiving FDA Breakthrough Device Designation, the team at Pulnovo Medical will gradually initiate global pre-market clinical trials for FDA approval, establish a professional sales network and channels covering major population regions in the Americas, Europe, and Asia, and build the leading Chinese brand in the treatment of pulmonary hypertension using medical devices, helping more patients with pulmonary hypertension regain their health.