The road to a new era: how 30 years of 3D EP with PFA innovation are forging a $10B+ future

Over the past two years, driven by both technological breakthroughs and shifts in the market landscape, the electrophysiology (EP) sector has surged in prominence, becoming one of the most closely watched segments in the medical industry.

Electrophysiology procedures can be performed using either 2D or 3D techniques. 2D techniques rely on X-ray for positioning, while 3D techniques utilize magnetic and electrical technologies for precise localization. Currently, 3D-guided EP procedures have successfully replaced traditional 2D techniques as the mainstream approach in cardiac electrophysiology.

Reflecting on the industry's development, it has been exactly 30 years since the birth of 3D electrophysiology systems. Over these three decades, the transition from 2D to 3D technology followed a challenging path of generational replacement. Through innovation, 3D technology ushered in a new era for electrophysiology: 3D electroanatomical navigation systems have undergone iterative upgrades with continuously breakthrough performance; key products such as contact force-sensing catheters, intracardiac echocardiography (ICE) catheters, and high-density mapping catheters have emerged successively, steadily refining the catheter ablation solution supported by 3D systems; innovative procedures have accelerated their translation to clinical practice, with expanding indications. Through simultaneous advancements in technology, products, and techniques, 3D has ultimately become the mainstream in electrophysiology.

Innovation in electrophysiology continues to advance. The robust emergence of pulsed field ablation (PFA) technology is currently bringing new development opportunities and broad exploration potential to the field.

At this critical industry juncture connecting past and future, VCBeat will systematically outline the innovation evolution of the electrophysiology sector in China and globally, conduct in-depth analysis of technological and market developments, and explore future trends to provide valuable insights for the industry.

Clinically, catheter radiofrequency ablation has become one of the preferred treatments and most effective curative methods for the vast majority of tachyarrhythmias.

In ablation procedures, the importance of mapping technology cannot be overlooked. If radiofrequency ablation is compared to a "bullet," then mapping technology is the navigation system that precisely locks onto the "target" (the location of abnormal electrical activity). By recording electrical signals within the cardiac chambers, it locates the earliest activation point of abnormal electrical activity or key conduction areas, providing precise coordinates for the delivery of radiofrequency energy. This enhances the success rate of the procedure and reduces damage to healthy myocardial tissue.

Before 1995, catheter radiofrequency ablation primarily relied on two-dimensional imaging from X-ray scans for mapping. This approach had significant limitations: it only provided two-dimensional information, placing high demands on the operator; accuracy was relatively low, often leading to procedural failure; and the high levels of X-ray radiation posed serious health risks.

Addressing the limitations of 2D technology, Israeli scientist Professor Shlomo Ben-Haim founded Biosense and pioneered the development of the first-generation CARTO system—a cardiac 3D electroanatomical mapping system—in 1995. This milestone marked the gradual transition of the electrophysiology field into the 3D era.

The early CARTO system utilized magnetic-based localization technology. It employed a magnetic field generator placed beneath the examination table. As the mapping catheter moved within this field, it generated electrical currents. By analyzing changes in current vectors, the system determined the catheter’s relative position within a three-dimensional space defined by a reference electrode. This enabled real-time visualization and tracking of electrode catheter movement inside cardiac chambers and vessels, allowing precise identification of key ablation sites.

Professor Shlomo Ben-Haim's team also integrated a mapping and location memory function into the system. This feature enabled the ablation catheter to return to the optimal target site if it deviated during the procedure, thereby reducing the total number of ablations and avoiding prolonged operation time.

Compared to traditional 2D systems, the CARTO system enables 3D reconstruction of cardiac anatomy, clearly displaying the three-dimensional structure of the heart and blood vessels. It integrates intracardiac electrograms with the heart's spatial anatomy, allowing clinicians to easily maneuver and position catheters, thereby improving ablation success rates. The CARTO system also addresses issues inherent in conventional 2D X-ray localization, such as lack of visual clarity, limited safety, and significant radiation exposure.

Furthermore, constrained by the positioning accuracy of 2D systems, electrophysiology procedures were previously limited mainly to simple arrhythmia cases. The application of 3D systems has significantly expanded the range of indications, making radiofrequency ablation feasible for complex arrhythmias, particularly atrial fibrillation, atrial tachycardia, atrial flutter, and ventricular tachycardia.

With these multiple advantages, 3D electroanatomical navigation systems have progressively become the mainstream in electrophysiology procedures worldwide. Following the introduction of the CARTO XP system into China in 2002, the development of 3D technology gained rapid momentum across the country, marking the beginning of China's 3D era in electrophysiology. According to a Frost & Sullivan research report, the proportion of 3D cardiac electrophysiology procedures in China increased significantly—growing from 69.78% of all such procedures in 2017 to 82.31% in 2021—while 2D procedures declined correspondingly from 30.22% to 17.69%. This trend confirms 3D technology as the dominant approach in cardiac electrophysiology.

Looking back to 1996, Johnson & Johnson demonstrated foresight by recognizing the potential of 3D electrophysiology. The company acquired Biosense for an estimated $400 million to formally enter the cardiac electrophysiology field, later merging it with Cordis Webster (also acquired) to form Biosense Webster—now a leader in electrophysiology under Johnson & Johnson. With Johnson & Johnson's support, the global promotion of the CARTO system accelerated significantly.

Other multinational giants, including Abbott and Boston Scientific, also entered the field through acquisitions, launching their own 3D electrophysiology systems such as EnSite and Rhythmia. Taking the EnSite system as an example, it received European approval in 1998. Unlike the CARTO system, EnSite employs electric field-based localization, which can detect mapping catheters and radiofrequency ablation catheters connected to a low-energy current output device.

With multiple major players entering the market, the 3D electrophysiology landscape became increasingly dynamic. Companies enhanced their competitiveness and vied for market share by continuously optimizing and iterating their 3D systems and introducing innovative products.

After launching the 3D electroanatomical navigation system, Johnson & Johnson did not rest on its first-mover advantages but continued to optimize and iterate its products. In 2009, the company introduced the more revolutionary and epoch-making CARTO 3 system.

The CARTO 3 system combines the strengths of both magnetic and electric field localization, utilizing hybrid magnetic and electric mapping technology. This enables real-time, precise visualization of all intracardiac catheters, significantly accelerates cardiac chamber modeling, and supports rapid reconstruction during catheter movement. It achieves synchronization of cardiac anatomy and electrophysiological information while producing high-resolution cardiac models. The system also features patient position compensation, allowing immediate automatic correction if the patient moves during the procedure, thereby ensuring uninterrupted progress and consistent outcomes.

To this day, hybrid magnetic-electric localization remains the most advanced and mainstream technology in the industry. Years later, companies such as Abbott and MicroPort EP have also launched 3D systems based on this dual-localization approach. Over 15 years, Johnson & Johnson has iteratively upgraded CARTO 3 through versions V6, V7, and the current V8, with continuous enhancements to its supporting software. The latest version incorporates artificial intelligence and machine learning capabilities, further strengthening the product's competitiveness.

It is worth noting that while the first-generation 3D system, CARTO XP, was primarily used for atrial fibrillation procedures, the introduction of CARTO 3 is widely regarded within the industry as having propelled the electrophysiology field into a true "full 3D era." Its revolutionary breakthroughs are reflected in two key aspects: first, all catheters became visible in 3D, significantly enhancing procedural visualization; second, its application expanded to encompass more complex ventricular arrhythmias in electrophysiology procedures.

In 2011, the CARTO 3 system received approval from China's National Medical Products Administration (NMPA) and was subsequently introduced and installed in major hospitals across the country. This marked China's gradual alignment with global innovation trends, entering the comprehensive 3D era of cardiac electrophysiology.

Beyond 3D electroanatomical navigation systems, companies have also developed numerous complementary surgical instruments tailored for 3D procedures. Among these players, Johnson & Johnson is recognized as an innovation leader in the electrophysiology field.

Taking the development of contact force technology—one of the most significant innovations in electrophysiology—as an example, the inherent limitation of 3D procedures was the inability to visually assess catheter-tissue contact. Previously, clinicians had to rely on subjective tactile feedback and personal experience to estimate contact between the catheter tip and myocardial tissue. This approach not only hindered accurate evaluation of ablation efficacy but also posed challenges for trainees mastering the procedure.

To address this, Biosense Webster, under Johnson & Johnson, pioneered the Thermocool SmartTouch catheter—a representative product in contact force monitoring technology. Unlike conventional radiofrequency ablation catheters, this device enables real-time measurement of contact force between the catheter tip and the cardiac wall. It better supports operators in performing procedures by effectively preventing complications caused by excessive contact force (such as tissue damage) or insufficient force leading to incomplete ablation. Quantifying contact force also shortens the learning curve for physicians and contributes to improved long-term treatment success rates.

In addition to Johnson & Johnson, Abbott has also introduced its own contact force-sensing catheters. Today, radiofrequency ablation guided by quantified contact force monitoring is widely recognized as an effective treatment for complex arrhythmias such as atrial fibrillation and has been extensively adopted in developed countries and China.

Another core product in 3D procedures is the high-density mapping catheter. Mapping serves as the foundation for catheter ablation in treating cardiac arrhythmias. Physicians rely on diagnostic mapping catheters to rapidly construct clear cardiac chamber models and accurately locate ablation targets using various potential signals, thereby ensuring precise ablation. Traditional mapping catheters, with their lower electrode density, often provide insufficiently accurate information, leading to suboptimal outcomes in some ablation therapies.

With 3D systems like CARTO 3, high-density mapping has brought revolutionary advancements to electrophysiology procedures. It has upgraded from traditional point-by-point mapping to multipolar simultaneous mapping, enabling rapid anatomical model generation. This provides physicians with richer intracardiac potential data, reveals mechanisms of complex arrhythmias, and shortens procedure time while enhancing both safety and effectiveness. Today, catheter radiofrequency ablation guided by high-density mapping is recognized as one of the most advanced treatment methods for atrial fibrillation.

Supported by innovative products, breakthrough technologies, and a professional training system, Johnson & Johnson's electrophysiology business has continued to grow. According to the research report Electrophysiology Devices: Key Players In A Fast-Growing Market published by Hedgedequity, Johnson & Johnson captured approximately 40% of the global electrophysiology device market in 2015, establishing itself as the recognized leader in cardiac electrophysiology.

With the successive approvals of innovative products such as contact force-sensing catheters and high-density mapping catheters, catheter ablation procedures supported by 3D systems have been continuously refined, and the value of full 3D electrophysiology has become increasingly evident. A 2016 paper by Dr. Yao Yan and Professor Zhang Shu from Fuwai Hospital, titled Clinical Electrophysiology Has Entered the Era of "Full 3D Mode", highlighted that the full 3D electrophysiology approach significantly reduces radiation exposure during electrophysiology studies and treatments for various arrhythmias, minimizing potential radiation risks for both medical staff and patients. It also lowers the technical difficulty of clinical electrophysiology procedures, shortens the learning curve for early-career physicians, expands the indications for catheter ablation, improves success rates, and reduces complications.

However, under the technical constraints of that time, achieving reliable block at the mitral isthmus line remained challenging. A key obstacle was the Marshall ligament—located epicardially and encased in adipose tissue—which proved difficult to effectively ablate using radiofrequency energy alone.

In 2019, Professor Sang Caihua and his team performed the first Marshall vein ethanol ablation, creatively overcoming this technical hurdle. Furthermore, Professor Sang innovatively integrated this approach with the "2C3L" technique, developing an upgraded "2C3L" strategy. Under the leadership of Professors Jiang Chenyang, Dong Jianzeng, and Ma Changsheng, they initiated the PROMPT-AF study in collaboration with 12 domestic medical centers to validate the clinical value of the upgraded approach.

In 2024, the PROMPT-AF findings were selected as a late-breaking presentation at the American Heart Association Scientific Sessions and published in the prestigious journal JAMA. The study confirmed that the upgraded "2C3L" strategy not only overcomes the limitations of conventional linear ablation but also offers multiple therapeutic advantages: it reinforces left pulmonary vein isolation, modulates cardiac autonomic innervation, and eliminates non-pulmonary vein triggers of atrial fibrillation. This approach is recognized as one of the most groundbreaking new strategies for persistent AF ablation in recent years.

The STABLR-SR strategy proposed by Professor Chen Minglong's team at Jiangsu Province Hospital has also gained significant international recognition. STABLR-SR builds upon the conventional "pulmonary vein isolation" by incorporating precise, individualized ablation of targeted substrates. Due to its demonstrated efficacy, this approach has been repeatedly incorporated into international atrial fibrillation guidelines and global expert consensus documents, achieving worldwide adoption and being referred to by international peers as the "Nanjing Approach." In last year's global expert consensus, this ablation strategy was ranked first among Class II recommendations.

Beyond procedural innovations, the concept of "Green Electrophysiology" advocated by Chinese clinical experts has also received broad international acceptance. The integration of 3D systems with mature intracardiac echocardiography (ICE) technology has enabled the possibility of low- to zero-radiation procedure environments. Against this backdrop, Chinese electrophysiology clinical experts began promoting the Green EP concept around 2016 and published a Chinese expert consensus in 2023. In recent years, both the Green EP concept and the establishment of green electrophysiology laboratories have been highly regarded by the international community.

The hallmark of Green Electrophysiology technology is its low- or zero-radiation approach, significantly reducing radiation exposure for both patients and operators during procedures. The medical community has long sought ways to minimize the hazards of X-ray radiation in electrophysiology treatments. The advent of the full 3D electrophysiology era has laid the foundation for low- and zero-radiation Green EP.

Utilizing systems such as CARTO 3, leading Chinese clinical experts including Professor Liu Xiaoqing and Professor Yu Ronghui have successfully performed zero-radiation atrial fibrillation treatments. They pioneered techniques such as fully zero-radiation catheter ablation, zero-radiation transseptal puncture, and radiation-free electrophysiology laboratories, positioning China at the forefront of international electrophysiology practice.

Notably, Professor Yu Ronghui performed the world's first fully 3D-guided, completely radiation- and ultrasound-free interventional procedure, attracting considerable attention and study from electrophysiologists worldwide.

Several years later, the 2023 Chinese Expert Consensus on the Establishment of Radiation-Free Cardiac Electrophysiology Laboratories and Related Techniques was formally released. This document was spearheaded by Professors Ma Changsheng and Jiang Chenyang and compiled with the participation of 44 experts. Innovations in scientific technology and the continuous exploration by Chinese electrophysiology specialists have made radiation-free cardiac electrophysiology procedures increasingly safe and reproducible. This consensus is accelerating the advancement of China's electrophysiology field toward a greener, safer, and more efficient future.

In recent years, multiple manufacturers have launched 3D electroanatomical navigation systems and related procedural products. However, with the emergence of pulsed field ablation (PFA) as a new-generation technology in electrophysiology, competition in the market landscape has intensified.

Compared to radiofrequency ablation and cryoablation, PFA offers advantages such as tissue selectivity and non-thermal effects, providing significant benefits in treatment safety and ablation efficiency. As a result, PFA is regarded as the future mainstream technology in electrophysiology. Internationally, PFA has already begun replacing radiofrequency and cryoablation in certain applications.

Professor Liu Shaowen of Shanghai General Hospital previously stated in a media interview: "As an energy modality, pulsed field ablation must integrate 3D mapping, contact force monitoring, and lesion quantification—similar to radiofrequency ablation—to achieve precise, 'point-and-ablate' accuracy and substantial progress in atrial fibrillation treatment. Only then can operators reliably assess the effectiveness of ablation."

Professor Zhang Fengxiang of Jiangsu Province Hospital added: "In PFA procedures for atrial fibrillation, 3D technology is essential. It helps evaluate catheter contact and identify gaps in ablation lesions. We are now in the era of Green Electrophysiology, and only 3D systems can enable truly green procedures."

In this new competitive landscape, Johnson & Johnson remains at the forefront with the recent approval of its first CARTO-integrated pulsed field ablation product, VARIPULSE, in China earlier this year. The full integration of CARTO 3 with VARIPULSE leverages the platform's precise 3D modeling and localization capabilities to facilitate low- to zero-radiation procedures. To date, multiple hospitals in China have successfully performed "zero-radiation Green PFA procedures" using the CARTO 3 system.

Currently, multi-energy ablation technology combining 3D guidance, radiofrequency, and pulsed field energy has become a major industry focus. The rise of PFA technology presents new development opportunities and exploration potential for China's electrophysiology sector. Amid growing participation from numerous companies, Johnson & Johnson—continuing its innovation leadership—has launched the STSF DE pulsed/radiofrequency dual-energy ablation catheter, which integrates both energy modalities. This latest-generation ablation catheter has already received CE marking in the European Union and is expected to soon enter the Chinese market, heralding a new era in electrophysiology.

From 3D radiofrequency ablation to 3D multi-energy ablation combining radiofrequency and pulsed fields, innovation in the electrophysiology industry has never ceased. Over the past 30 years, since entering the 3D era, the field has consistently rewritten its landscape through technological advances. We have witnessed the evolution from first-generation 3D systems to new platforms integrated with artificial intelligence and machine learning; the shift from experience-dependent "approximate maneuvering" to quantitatively guided contact force monitoring; and the transition from high-dose X-ray exposure to low- and zero-radiation procedures. Each technological leap has elevated the diagnostic and therapeutic capabilities of electrophysiology, continuously enhanced the clinical value of 3D EP procedures, reduced risks, and shortened the learning curve—steadily establishing 3D as the mainstream approach.

This 30-year development journey has proven that innovation is the core driver enabling the electrophysiology sector to break through bottlenecks and achieve rapid growth. Now, at the threshold of the next three decades, we believe innovation will continue to be the dominant theme.

The integration of artificial intelligence with medical devices continues to deepen, promising to advance the field of electrophysiology toward greater intelligence and optimize diagnostic-therapeutic models and procedural techniques. While surgical robotics remains in early exploration for EP applications, its potential positions it as a future breakthrough area. Intracardiac echocardiography (ICE) has already progressed from 2D to 4D (real-time 3D) imaging, a technological evolution that will further refine electrophysiology procedures and clinical outcomes, positioning ICE as a pivotal innovation reshaping the future of the field. Beyond pulsed field ablation, new ablation energy sources may emerge, or novel application scenarios may be developed. Innovation in electrophysiology continues to inspire anticipation.

Looking ahead, whichever player seizes the commanding heights of innovation will lead the future direction of the electrophysiology industry.