Maiwei Medical Completes Enrollment in Pivotal Clinical Trial for World’s First Nanosecond Pulsed Field Ablation (nsPFA) System for Atrial Fibrillation

Recently, the world’s first nanosecond pulsed field ablation (nsPFA) system for atrial fibrillation, developed by Shenzhen Maiwei Medical, has successfully completed enrollment for its registration clinical trial. This system is currently the only nsPFA product globally to have entered registration clinical trials. Owing to its superior performance and the technological advantages of third-generation nanosecond pulsed field ablation (nsPFA), the product has received high acclaim from clinical experts. nsPFA represents the future of pulsed field ablation (PFA) technology, addressing a series of clinical pain points associated with second-generation PFA technologies. It took Maiwei Medical only two years from its establishment to complete patient enrollment for the nsPFA product’s clinical trial, demonstrating the team’s exceptional execution capabilities and profound technical expertise.

nsPFA Product Photo

China has a population of 20 million patients with atrial fibrillation (AF), which is increasing by hundreds of thousands each year. According to the latest Chinese guidelines for AF management released in 2022, “Atrial Fibrillation: Current Understanding and Therapeutic Recommendations,” catheter ablation is significantly superior to pharmacological therapy in maintaining sinus rhythm for paroxysmal AF; thus, catheter ablation may be selected as a first-line treatment option for patients with symptomatic paroxysmal AF. For newly diagnosed AF patients with cardiovascular risk factors, early rhythm control strategies, including catheter ablation, should be actively implemented. The market size for cardiac electrophysiology ablation is projected to reach tens of billions of yuan by 2030.

Pulsed Field Ablation (PFA) is a revolutionary ablation technique based on high-voltage pulsed energy and the non-thermal irreversible electroporation (IRE) effect. With technical advantages such as tissue selectivity, non-thermal mechanisms, and high efficiency, PFA demonstrates significant superiority over radiofrequency and cryoablation in terms of procedural safety and ablation efficacy. Consequently, PFA is regarded as an emerging alternative technology in the field of cardiac electrophysiology ablation. Driven by its demonstrated clinical value and substantial market potential in cardiac electrophysiology, numerous companies have strategically entered this space over the past two years, making it one of the most competitively intense tracks in the innovative medical device sector.

Existing PFA cardiac ablation technologies—including Farapulse, a pioneer in the PFA field acquired by Boston Scientific—utilize second-generation microsecond pulsed field ablation. During procedures, issues such as patient movement and muscle contractions necessitate stringent anesthesia requirements, thereby increasing procedural complexity. Intraoperatively, gas generation from blood electrolysis during discharge may elevate the risk of stroke. Postoperatively, patients may experience high one-year recurrence rates or pseudo-isolation. These challenges significantly impede the clinical adoption and commercialization of PFA technology.

Maiwei Medical’s nsPFA atrial fibrillation ablation system, which has completed enrollment in its registration clinical trials and possesses independent intellectual property rights, represents a third-generation PFA technology designed to address the aforementioned limitations of existing PFA ablation techniques. Leveraging the team’s over 20 years of expertise in high-voltage pulse research and China’s leading all-solid-state high-voltage pulse core technology, Maiwei Medical’s nsPFA product is the world’s first PFA cardiac ablation system capable of delivering high-repetition-rate nanosecond-level high-voltage pulses. By utilizing nanosecond pulses, the system optimizes therapeutic electric field distribution, reduces muscle contraction, and enhances procedural safety, thereby resolving critical challenges associated with current PFA technologies, such as severe muscle contraction and stringent anesthesia requirements. This innovation enables PFA atrial fibrillation ablation procedures to be performed under analgesia alone, laying a solid foundation for the large-scale clinical adoption and promotion of PFA technology. Thanks to its superior performance and clinical outcomes, Maiwei Medical’s nsPFA product has received high acclaim from numerous clinical experts during enrollment at more than ten Grade IIIA hospitals across China. In over 160 clinical trial cases, there were no complications such as pulmonary vein stenosis, phrenic nerve injury, or atrio-esophageal fistula, nor were there any device-related adverse events. The system demonstrates exceptional ablation efficiency, with procedures completed in as little as twenty minutes. The immediate pulmonary vein isolation success rate was 100%, and available follow-up data indicate significant clinical efficacy with an extremely low recurrence rate.

 3D Mapping Results After nsPFA Pulmonary Vein Isolation

Notably, Maiwei Medical’s nsPFA system is not only the world’s first but also the sole nsPFA product globally to have entered registrational clinical trials. Comparable products developed by Pulse Biosciences (a Nasdaq-listed company in the United States), the Mayo Clinic, and Old Dominion University’s Frank Reidy Research Center for Bioelectrics remain in the preclinical stage. The completion of patient enrollment in this clinical trial marks a significant step forward for Maiwei Medical’s nsPFA atrial fibrillation ablation system on the path to regulatory approval, and represents a major breakthrough in the company’s strategic layout of its multimodal micro-invasive therapeutic energy platform.

Maiwei Medical focuses on the research and development of minimally invasive and non-invasive therapeutic devices, as well as integrated diagnostic and therapeutic medical equipment. The nsPFA atrial fibrillation ablation system is its first innovative product launched in the field of cardiac electrophysiology and on its pulsed field ablation (PFA) technology platform. In the future, leveraging its technical advantages in high-repetition-rate, high-voltage nanosecond pulses, Maiwei Medical will continue to expand indications to include supraventricular tachycardia (SVT), ventricular tachycardia (VT), and other conditions, thereby solidifying its leading position in core PFA technologies. Meanwhile, as part of a comprehensive solution for cardiac electrophysiological ablation procedures, Maiwei Medical is actively developing an in-house magnetic-electric dual-location 3D mapping system for cardiac electrophysiology. Built upon extensive expertise in weak signal acquisition and processing, along with a specialized electrophysiology R&D team, a high-density 3D mapping system that seamlessly integrates with the nsPFA system is poised for imminent launch.

Multimodal energy serves as the cornerstone of minimally invasive and non-invasive therapies. However, different energy modalities possess distinct advantages and are indicated for entirely different clinical conditions. Therefore, to meet clinical treatment needs, it is not only essential to focus on the development of energy platforms and technologies, but more importantly, to effectively align the specific characteristics of each energy modality with the therapeutic requirements of its indications, thereby maximizing their technical benefits. This demands that product R&D teams possess robust technical expertise, extensive knowledge reserves, and rapid learning capabilities—qualities exemplified by the team at Maiwei Medical.

The founding team of Maiwei Medical previously developed China’s first domestically produced “NanoKnife” product and a series of ultrasound-based therapeutic devices, accumulating over 16 years of technical expertise in biomedical engineering and tumor ablation. Consequently, in addition to the field of cardiac electrophysiology, Maiwei Medical has rapidly expanded its portfolio with innovative products in tumor ablation. Currently, another world-first product—the Multimodal Pulsed Field Tumor Ablation System—has entered clinical trials. By integrating pulsed field ablation (PFA) with radiofrequency ablation (RFA), this system addresses issues associated with existing “NanoKnife” technologies, such as needle-track metastasis and bile duct injury caused by tip heating. Studies have reported that the risks of these two complications with the “NanoKnife” are 26% and 24%, respectively. The new system demonstrates superior clinical efficacy and safety, and it can be combined with chemotherapy and immunotherapy agents to facilitate research and applications in drug-device combination therapies.

Owing to the superior penetrability and controllable energy delivery of ultrasound, recent clinical trial results for Paradise, an ultrasound-based renal denervation (RDN) system launched by Recor Medical in the United States, suggest that ultrasound RDN may offer better clinical outcomes. Leveraging years of accumulated expertise in integrated ultrasound diagnosis and therapy, Maiwei Medical has developed the industry’s only ultrasound RDN system capable of both ultrasound nerve mapping and ablation. This system enables rapid circumferential ablation of sympathetic nerves surrounding the renal arteries within seconds while effectively protecting the vascular intima, thereby minimizing the risk of renal artery stenosis. The product is currently in the stage of regulatory testing submission and is poised to initiate clinical trials.

Maiwei Medical's Ultrasound RDN System

In just two years, Maiwei Medical has rapidly developed four industry-leading multimodal energy platforms—pulsed field ablation, radiofrequency, ultrasound, and plasma—leveraging its solid technical foundation, exceptional execution capabilities, and high R&D efficiency. Building on these advanced multimodal energy platform technologies, the company has established a portfolio of innovative therapeutic products in the fields of cardiac electrophysiology, tumor ablation, and hypertension treatment, addressing a total addressable market valued at hundreds of billions of yuan.

How has Maiwei Medical been able to rapidly develop several blockbuster products and establish a portfolio of four multimodal energy platforms in such a short period? The fundamental reason lies in its technological leadership, built upon years of accumulated expertise. The founding team of Maiwei Medical previously undertook the only National Key R&D Program project in the field of high-voltage pulses, titled “Development and Industrialization of High-Repetition-Rate High-Voltage Pulse Sources,” and successfully applied high-voltage pulse technology across multiple sectors, including testing, electric power, security, environmental protection, and healthcare. Dr. Tan Jianwen, founder of Maiwei Medical, formerly served as the head of the “Multimodal Imaging and Intelligent Precision Therapy” division at the State Key Laboratory of Ultrasound Medicine Engineering. He led numerous key projects funded by the National Natural Science Foundation of China and provincial/ministerial authorities, focusing on integrated ultrasound diagnosis and therapy, and has devoted over 16 years to in-depth research in the field of ultrasound therapy.

It is precisely due to the clinical advantages and market value demonstrated by nsPFA during clinical trials that the world’s first nsPFA atrial fibrillation ablation system, developed by Maiwei Medical, has been invited by the Ministry of Science and Technology of China to participate in the upcoming exhibition of a series of project achievements organized by the Ministry.

Looking ahead, Maiwei Medical will continue to refine its nsPFA system into a premier solution in the field of cardiac electrophysiology ablation, thereby enriching its comprehensive portfolio in this area. Meanwhile, the company will accelerate the R&D and registrational clinical trials of its product pipeline—including ultrasound-based renal denervation (RDN), multimodal liver ablation systems, and multimodal prostate ablation systems—leveraging its four multimodal energy platforms. Building on its current technological leadership, Maiwei Medical will further advance its overseas registration strategy and global patent layout, striving to become a world-class enterprise specializing in multimodal, minimally invasive therapeutic devices.