Shanghai, China – March, 2025 – Pulnovo Medical, a globally recognized pioneer in medical devices for pulmonary hypertension (PH) and heart failure (HF), proudly announces two major regulatory milestones in advancing pulmonary artery interventions. The Multi-pole Pulmonary Artery RF Ablation Generator(PHD360) has received approval from China’s National Medical Products Administration (NMPA), while the PFlexi Introducer Sheath has been cleared by both the U.S. FDA (November 2024) and NMPA (January 2025). These approvals mark a significant step forward in providing more precise, efficient, and safer interventional solutions for pulmonary hypertension (PH) and heart failure patients.

PHD360: Bringing Temperature-Controlled Precision to PADN

PHD360 is an upgraded next-generation PADN (Pulmonary Artery Denervation) generator, incorporating temperature-controlled technology to enhance precision and safety during ablation. Key improvements include:

· Temperature-Controlled Mode: Real-time monitoring adjusts energy output dynamically, ensuring safe and effective ablation.

· Optimized Energy Delivery: Prevents over- or under-ablation, improving treatment consistency.

· Enhanced User Experience: A modernized interface provides real-time insights into temperature, ablation progress, and procedure time.

With NMPA approval, PHD360 brings a new level of predictability and efficiency to PADN procedures, advancing PH and heart failure intervention strategies.

PFlexi: A Reliable Access Solution with FDA & NMPA Approval

PFlexi is a high-performance vascular access sheath designed for seamless and stable pulmonary artery interventions. Key benefits include:

· Smooth Navigation: A multi-segment design allows flexible and controlled movement through complex anatomies.

· Secure and Stable Support: Ensures a reliable conduit for device delivery, improving procedural success.

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With FDA and NMPA approvals, PFlexi is now recognized internationally as a trusted access solution for pulmonary interventions.

Pulnovo Medical continues to pioneer PADN advancements, offering comprehensive interventional solutions for PH and heart failure patients. These regulatory milestones reinforce Pulnovo’s commitment to delivering cutting-edge, innovative medical technologies to a global audience.