#China #Shenzhen #NMPA #Pulsecare Medical #NxPFA

Pulsecare Medical's Breakthrough in Atrial Fibrillation Treatment

Pulsecare Medical, a company at the forefront of cardiovascular intervention technologies, has made significant strides in the medical field with the announcement of its groundbreaking NxPFA™ system. Recently receiving approval from the National Medical Products Administration (NMPA) of China, this system introduces the world's first nanosecond pulsed field ablation (ns-PFA) technology for treating atrial fibrillation (AF). This marks not just a technological advancement but heralds the beginning of the PFA 3.0 era.

Understanding NxPFA™ Technology

The NxPFA™ system represents the next generation of pulsed field ablation systems designed for pulmonary vein isolation (PVI). Previous iterations of PFA technology faced limitations, such as excessive muscle stimulation and reliance on general anesthesia, which hindered broader acceptance and application. The NxPFA™, however, combines cutting-edge features designed to address these challenges seamlessly.

1. High-Frequency Nanosecond Pulses: Utilizing high-voltage nanosecond pulses, the system minimizes neuromuscular stimulation, allowing procedures to be performed under conscious sedation. This innovation greatly enhances patient comfort and reduces the risks associated with general anesthesia.
2. Basket-Shaped Catheter: The InteShot™ basket-shaped catheter ensures optimal contact between the electrode and the tissue, maximizing the effectiveness of the procedure while significantly shortening the time required.
3. Enhanced Safety Profile: It substantially lowers the risks of intravascular gas formation, which can lead to severe complications like stroke or systemic embolism. Additionally, it minimizes erythrocytic damage during procedures, thereby reducing the potential for kidney injury.

Proven Efficacy and Safety

The efficacy and safety of the NxPFA™ system have been validated through the SCENA-AF multicenter registration trial. This trial involved 166 patients suffering from paroxysmal atrial fibrillation and showcased remarkable results. Key outcomes included:

• - 100% Acute Pulmonary Vein Isolation Success Rate
• - 88.27% One-Year Treatment Success Rate (Per Protocol Set)
• - No Device-Related Serious Adverse Events Reported
• - Over 92.8% of Procedures Completed Under Conscious Sedation

These results not only confirm the NxPFA™'s robust performance but also underscore its potential to revolutionize AF treatment. In fact, it stands as the only PFA system globally to achieve one-shot PVI under conscious sedation with high success rates.

Impact on Cardiac Electrophysiology

Dr. Javen Tan, CEO of Pulsecare Medical, noted, "NxPFA™'s approval is not only a major milestone for Pulsecare Medical but also a transformative breakthrough for cardiac electrophysiology. With NxPFA™, we address critical clinical challenges and look forward to collaborating with global electrophysiology experts to shape the future of arrhythmia treatment. Our goal is to provide smarter tools to physicians and deliver safer, more effective, and comfortable therapies for patients."

About Pulsecare Medical

Founded in July 2021 and based in Shenzhen, Pulsecare Medical is committed to innovating cardiovascular multimodal therapeutic devices. Their cross-disciplinary team blends clinical expertise with engineering talent to develop advanced medical solutions. Pulsecare Medical aims to be at the forefront of minimally and non-invasive treatments, offering comprehensive solutions for cardiac electrophysiology and hypertension interventional therapies.

Pulsecare Medical is poised to lead the way in the next generation of cardiac treatments, with NxPFA™ set to transform how atrial fibrillation is addressed in clinical settings. With hands-on experience and validated outcomes, the company is committed to enhancing patient care through innovation and advanced technology.