Zhouling Medical Completes World's First Two Surgical Pulsed Field Ablation Procedures for Atrial Fibrillation, Prepares for Global Regulatory Submissions

The Pulsed Field Ablation Market, Which Continues to Heat Up, Has Welcomed Another Major Announcement.

In late February 2023, the independently developed product of Zhouling (Shanghai) Medical Device Co., Ltd. (hereinafter referred to as “Zhouling Medical”)Surgical Pulsed Field Ablation System (PFSA): The First Two Global Cases of Surgical Pulsed Field Ablation for Atrial Fibrillation Completed at Guangdong Provincial People's Hospital.

Two enrolled patients were a 57-year-old and a 48-year-old female with valvular atrial fibrillation, respectively, byGuangdong Provincial People's Hospital, the team of Professors Guo Huiming and Liu Jian from the Department of Cardiac Surgery at Guangdong Cardiovascular Institute successfullyCompleted. One patient underwent concurrent LIMA-to-LAD coronary artery bypass grafting, mitral valve repair, and tricuspid valve repair. Another patient underwent concurrent mitral valve replacement and tricuspid valvuloplasty, with extra-cardiac verification of conduction block and endocardial electrophysiological mapping performed under cardiopulmonary bypass. All procedures were completed as planned. Immediate post-treatment outcomes demonstrated successful electrical isolation of the pulmonary veins and left atrial appendage, with transmural ablation lines achieved. The patients converted to sinus rhythm intraoperatively, indicating significant surgical efficacy.

The successful execution of this surgery not only demonstrates Zhouling Medical’s significant breakthrough in the field of medical-engineering integration, but also represents the first publicly reported clinical trial of PFSA internationally, holding promise for providing new therapeutic solutions to more patients with complex atrial fibrillation.

PFSA Clinical Enrollment Site

In the treatment of atrial fibrillation (AF), the Cox-Maze III procedure is the most effective method for terminating AF and is considered the “gold standard” for surgical management. However, due to its excessive complexity, it is rarely used in clinical practice. Currently, the Cox-Maze IV procedure is the most widely applied surgical approach for AF. It primarily utilizes radiofrequency and cryoablation energy to replace the traditional “cut-and-sew” technique, significantly shortening operative time and reducing surgical risk. Nevertheless, its drawbacks include non-selective damage to myocardial tissue, potential injury to surrounding normal structures during the procedure—such as the adjacent esophagus, coronary arteries, and phrenic nerve—as well as concerns regarding treatment costs, recurrence rates, and the risk of collateral complications.

Pulsed Field Ablation (PFA) technology, with its tissue specificity and safety advantages during ablation, is considered the third potential approach in the field of atrial fibrillation (AF) ablation, poised to break the "ice" and "fire" dilemma of current AF ablation methods. It works by generating localized high-voltage differences through pulsed electric fields, creating irreversible nanoscale pores on cell membranes and causing leakage of cellular contents, thereby disrupting membrane stability. Compared to radiofrequency ablation and cryoablation technologies, PFA offers advantages such as tissue selectivity, non-thermal ablation, rapid electric field action, minimal tissue damage, and lower recurrence rates.

The first two PFSA procedures completed by Zhouling Medical successfully achieved electrical isolation of the atrium and pulmonary vein tissues, with the resulting ablationExcellent Transmural Permeability and Diameter Integrity, it offers unparalleled advantages over catheter ablation and current surgical ablation in terms of operational convenience, procedure time, and completeness of ablation, demonstrating good efficacy for atrial fibrillation; patients with atrial fibrillation complicated by complex structural heart disease derive even greater benefit.

The results demonstrated that PFSA offers a short discharge time, ease of operation, and significant therapeutic efficacy. It does not cause myocardial perforation due to steam explosion during discharge, thereby substantially reducing the complexity and risks associated with the surgical procedure. Furthermore, leveraging the high tissue selectivity of PFSA, it avoids damage to the phrenic nerve, other nerves, coronary arteries, and surrounding structures. Additionally, during each ablation discharge, the system is equipped withAblation Self-Test Function, avoiding blind procedures and redundant treatments, thereby effectively achieving ablationIntelligenceClosed-loop. While ensuring therapeutic efficacy, procedures that previously required 30–45 minutes can now be completed in just a few minutes, achieving a significant improvement in surgical efficiency.

During the project’s research and development, Zhouling Medical has adhered to the principle of “driving technological innovation through clinical-needs-oriented medical-engineering integration,” in collaboration withGuangdong Provincial People's Hospital, Guangdong Cardiovascular Institute: The Team of Professors Guo Huiming and Liu JianThrough close collaboration and in-depth engagement at the frontline, we thoroughly identified clinicians’ clinical needs and treatment pain points, leading to specialized optimization of the surgical pulsed ablation energy platform.

Leveraging the clinical characteristics of atrial fibrillation (AFib) and the developmental trends in pulsed field technology, and integrating the advantages of advanced energy platforms with extensive expertise in active medical device technologies, the team pioneered the successful surgical ablation of AFib using pulsed electric fields. The system and instruments utilized in this procedure were independently developed by Zhouling Medical, possessing full independent intellectual property rights.

Traditional ablation devices may encounter issues such as incomplete ablation, significant energy dissipation, and a higher risk of complications due to damage to certain low-impedance tissues (e.g., the esophagus and coronary arteries). To address this clinical challenge, Zhouling Medical, in collaboration with the teams of Professors Guo Huiming and Liu Jian, has developed a uniquely designedCurved-tip ablation forceps and flexible ablation pen,to meet the therapeutic needs of different types of lesions, greatly improving the convenience and success rate of surgical atrial fibrillation procedures.

Figure Caption: Zhouling Medical's Innovatively Self-Developed PFSA Ablation System

Atrial Fibrillation (AFib) is the most common arrhythmia.

During atrial fibrillation, impaired atrial contractile function predisposes to blood stasis within the atria, leading to thrombus formation. These thrombi can travel through the bloodstream to various parts of the body, causing multi-organ embolism and resulting in conditions such as cerebral embolism, pulmonary embolism, coronary artery embolism, renal artery embolism, and peripheral arterial embolism. Furthermore, the incidence of stroke in patients with atrial fibrillation is more than five times higher than that in the general population. Stroke associated with atrial fibrillation is characterized by high rates of disability, mortality, and recurrence.

According to the study “Prevalence and risk of atrial fibrillation in China: A national cross-sectional epidemiological study,” published by Professor Zheng Qiangsun and other experts from the Second Affiliated Hospital of Xi’an Jiaotong University in The Lancet Regional Health – Western Pacific in April 2022, the overall prevalence of atrial fibrillation among adults in China is 1.6%, which translates to an estimated 22 million patients with atrial fibrillation in China currently. Furthermore, the prevalence of atrial fibrillation is positively correlated with age, increasing as individuals grow older. With China’s economic development and rising life expectancy, the volume of electrophysiological procedures for atrial fibrillation will continue to grow, leading to a sustained expansion of the market size for atrial fibrillation ablation.

Zhouling Medical’s PFSA product, as an innovative treatment option with lower risks and fewer complications, will also benefit more patients with atrial fibrillation.

Zhouling Medical, established in 2021, is an R&D-driven innovative medical device company dedicated to providing high-quality medical devices to patients in China and worldwide for the treatment of life-threatening conditions affecting the cardiovascular and cerebrovascular systems, respiratory system, and other critical areas. The company’s technical team, led by R&D professionals returning from the United States and Germany, boasts decades of development and research experience in the medical equipment field, maintaining a leading technological position within China.

Zhouling Medical operates a standardized GMP-certified manufacturing facility spanning approximately 1,000 square meters, ensuring ample production capacity across multiple product lines. The company is equipped with comprehensive physical and active medical device laboratories, along with a modern office environment, to meet the strategic needs of sustainable corporate development.

Global clinical experience with Pulsed Field Ablation (PFA) has demonstrated the significant appeal of this market, while Chinese and U.S. companies now stand on equal footing. By completing the world’s first two cases of surgical PFA for atrial fibrillation, Zhouling Medical has undoubtedly made a technological breakthrough, opening up new avenues for the treatment of atrial fibrillation.

It is reported that Zhouling Medical will soon initiate a multicenter registrational clinical trial and simultaneously submit applications for CE marking and FDA approval. As clinical and real-world data continue to accumulate, the advantages of Zhouling Medical’s innovative ablation system are expected to become increasingly evident, offering more safe and effective Chinese solutions to address the challenges in atrial fibrillation treatment.

Guangdong Provincial People's Hospital, Guo Huiming

Chief Physician, Professor, and Doctoral Supervisor. Deputy Director of the Department of Cardiac Surgery at Guangdong Provincial People’s Hospital and Guangdong Cardiovascular Institute; Leader of three disciplines: Minimally Invasive Surgery Group, Surgical Treatment of Coronary Artery Disease, and Surgical Treatment of Atrial Fibrillation. He serves as a member of the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS), holds membership in the American Association for Thoracic Surgery (AATS), stands as a Standing Committee Member of the Chinese Chapter of the Asian Society for Valvular Heart Disease, Vice Chairman of the Minimally Invasive Cardiovascular Surgery Committee under the National Expert Committee on Cardiovascular Diseases, Standing Committee Member of the Cardiovascular Surgery Branch of the Chinese Medical Doctor Association and Deputy Leader of its Minimally Invasive Surgery Group, Committee Member of the Thoracic and Cardiovascular Surgery Branch of the Chinese Medical Association, Vice Chairman of the Atrial Fibrillation Committee of the Chinese Research Hospital Association, and Vice Chairman of the Cardiovascular Surgery Branch of the Guangdong Medical Association, among other positions.

Honored with the “Golden Scalpel Award,” ranked first in minimally invasive cardiac surgery on the “Top 100 Famous Chinese Doctors List,” and awarded the title of “National Famous Doctor: Exemplary Professionalism.” Recipient of numerous awards, including the Second Prize of the Chinese Medical Association, the First Prize of Guangdong Natural Science Award, and the Second Prize of Guangdong Science and Technology Award. Authored more than 80 SCI-indexed papers.

Guangdong Provincial People's Hospital, Liu Jian

Associate Chief Physician, M.D., Master’s Supervisor; Team Leader of Cardiac Surgery at Guangdong Provincial People’s Hospital; Deputy Director of the Expert Committee of the Atrial Fibrillation Center at Guangdong Provincial People’s Hospital. Visiting Scholar at the Heart Center, Linköping University Hospital, Sweden, and the Deutsches Herzzentrum Berlin (DHZB).

Committee Member of the Young Committee of the Thoracic and Cardiovascular Surgery Branch, Chinese Medical Association; Committee Member of the Young Committee of the Cardiovascular Surgeons Branch, Chinese Medical Doctor Association; Committee Member of the Professional Committee on Atrial Fibrillation Prevention and Treatment, Chinese Research Hospital Association; Academic Committee Member of the Interventional Therapy Technology Committee, China Chapter of the Asian Society for Valvular Heart Disease; Committee Member of the Minimally Invasive Cardiovascular Surgery Professional Committee, National Expert Committee on Cardiovascular Diseases; Member of the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS); Deputy Director of the Expert Committee of the Atrial Fibrillation Center, Guangdong Provincial People’s Hospital; Committee Member of the Arrhythmia Professional Committee, Cardiovascular Surgeons Branch, Chinese Medical Doctor Association; Committee Member of the Minimally Invasive Professional Committee, Cardiovascular Surgeons Branch, Chinese Medical Doctor Association; Youth Committee Member of the First Committee of the Immunotherapy Engineering Branch, Chinese Society of Biomedical Engineering; Editorial Board Member (Young and Middle-aged) of the *Chinese Journal of Biomedical Engineering*; Reviewer for journals including the *Chinese Journal of Biomedical Engineering* and the *Chinese Journal of Clinical Thoracic and Cardiovascular Surgery*.