Global Landscape of 36 PFA Systems: Rapid Commercialization and Three Major Product Evolution Trends Emerge

The main mechanism of atrial fibrillation is the abnormal electrical activity of atrial muscles in areas such as the pulmonary veins. Catheter ablation achieves pulmonary vein isolation (PIV) through different methods, blocking abnormal signal conduction and restoring the heart to its normal rhythm, thereby treating atrial fibrillation.Atrial fibrillation is one of the main indications for pulsed field ablation (PFA).

Over the past two decades, radiofrequency and cryoablation have been the mainstream technologies in the field of cardiac ablation. However, with its advantages of short ablation time, effective treatment, and minimal side effects, pulsed field ablation (PFA) has emerged as "the dominant cardiac ablation technology for the next decade" and has seen rapid clinical and commercial progress in recent years.

Currently, there are four products globally approved by the NMPA, respectively from Jinjiang Electronics, Denovo Electrophysiology, Boston Scientific, and Medtronic; Boston Scientific and Medtronic are the two global companies that have simultaneously received approval from the NMPA, FDA, CE, and Japanese regulatory authorities for the treatment of atrial fibrillation using PFA.

Farapulse, under Boston Scientific, is the pioneer of PFA. In July 2024, Boston Scientific released its Q2 financial report for 2024. Thanks to the Farapulse system, sales in its electrophysiology business increased by 125% year-over-year, injecting strong momentum into Boston Scientific's development in the cardiovascular field and bringing significant confidence to the growth of the PFA market.

Medtronic's PulesSelect is the world's first PFA product to simultaneously receive CE, FDA, Japanese regulatory, and NMPA approval. In Medtronic's Q1 fiscal year 2025 earnings report released on August 20, it was mentioned that the cardiac ablation solutions business achieved mid-single-digit growth driven by the PulseSelect pulsed ablation system.

According to Frost & Sullivan data, the市场规模 of PFA in China is expected to reach 1.3 billion yuan by 2025 and maintain rapid growth, reaching 16.3 billion yuan by 2032, with a CAGR of 43.73% during this period. The proportion of the PFA market规模 in the overall electrophysiology device market规模 is also expected to continuously increase, rising from 8.18% in 2025 to 38.87% in 2032. The PFA market holds significant potential.

In order to understand the current development of FDA products globally, we have reviewed 36 PFA products from 30 companies worldwide and found that since 2023, the global PFA market has been extremely active, with products...ExpandIndications, Catheter/Mapping Technology UpgradeThere are many excellent performances.

It should be emphasized that the table content is partially organized by VCBeat based on publicly available information, and does not include all product lines of the company/all functions or parameters of the product. Moreover, the indications are limited to the electrophysiology field and do not include pulsed ablation for tumors.

Observing the indications of the products in the table, it can be seen that the indication for the vast majority of PFA products is paroxysmal atrial fibrillation. Paroxysmal atrial fibrillation refers to atrial fibrillation that terminates spontaneously or with intervention within 7 days of onset, currently accounting for one-third of all atrial fibrillation cases. Clinically, if not intervened, more than 20% will progress to persistent atrial fibrillation in the next three years.

The occurrence and persistence mechanisms of persistent atrial fibrillation are more complex, and both catheter ablation and thoracoscopic surgical ablation are relatively difficult for maintaining sinus rhythm.

Medtronic's PulseSelect is the first PFA product approved by both NMPA and FDA for use in both paroxysmal atrial fibrillation and persistent atrial fibrillation, which is also the biggest advantage of Medtronic's FDA approval compared to other products.

But other manufacturers have not been idle, instead accelerating the research on product indications. According to the梳理results, Boston Scientific launched relevant research on the FARAVIEW software module in April this year to treat patients with paroxysmal and persistent atrial fibrillation.

Among Chinese manufacturers,HuiTai MedicalIn the March 2023 announcement, it was mentioned that its magnetic pressure ablation system is the first domestically produced product of its kind to complete patient enrollment for a pre-market clinical trial for persistent atrial fibrillation.Jinjiang ElectronicsIn March 2024, a clinical study on the treatment of persistent atrial fibrillation using pulsed electric field ablation was successfully conducted.Heart Navigation MedicalThe integrated 3D PFA product portfolio, "Magnetic and Electric 3D + Magnetic and Electric PFA," is also expected to become the world's only PFA product portfolio capable of mapping persistent atrial fibrillation and achieving personalized ablation; September, Jianhu MedicalCompletion of the First Clinical Study on the Treatment of Persistent Atrial Fibrillation Using an Innovative Integrated System Combining Dielectric Three-Dimensional and Nanosecond Pulsed Technologies.

The complete PFA product includes an energy device, ablation catheter, and mapping platform, which respectively serve to generate and control the output of pulsed electric field energy, directly act on myocardial tissue, precisely locate lesions, and evaluate ablation effects. As ablation platforms continue to mature, dual-energy/multi-energy platforms that combine various technological advantages have become a new trend in research and development, with various innovative products emerging.

The dual-energy technology in a single catheter refers to the integration of multiple energy forms within the same ablation catheter, particularly the combination of pulsed electric fields with radiofrequency or cryogenic energy, to achieve more efficient and safer ablation outcomes.

Currently, Johnson & Johnson's Thermocool SmartTouch SFF dual-energy catheter can switch between radiofrequency and pulsed electric field energy, while possessing the dual ablation capabilities of both radiofrequency ablation and pulsed electric field. Medtronic’s Sphere-9 lattice ablation catheter, used in conjunction with the HexaGen ablation generator and saline irrigation pump, offers both radiofrequency and pulse ablation without the need to move the catheter or connection lines, meeting ablation needs for different areas. Adagio’s Pulse Freeze Ablation (PFCA) technology from the United States combines pulsed electric field and cryoablation technologies, providing ultra-low temperature cryoablation and pulse ablation through a single catheter.

However, the dual-energy technology in a single catheter still faces technical challenges such as output control and stability of different energy levels, catheter design and manufacturing, safety protection, and reliability assurance. Currently, there are no relatively mature related products available in the market.

At the same time, there are alsoChinese companies have highly integrated pulse ablation and mapping functions, allowing for全流程 operations such as three-dimensional modeling of cardiac tissue, electrophysiological mapping, pulse ablation, and assessment of ablation effects to be performed using one or more specially designed catheters.This integrated design can improve the precision and safety of surgery, enhance treatment outcomes, and reduce operation time, among other benefits.

According to public information, Boston Scientific, Medtronic, Canadian Kardium, Jinjiang Electronics, Denovo EP, HT Medical, and Cardiovoyage Medicine all have PFA products with both pulse ablation and mapping functions.

Mapping systems are important tools for doctors to track the source of diseases and specify ablation plans. According to different mapping technologies, they can be divided into 2D mapping and 3D mapping. 3D magnetic and electrical positioning technology has the advantages of accurate modeling, high positioning and navigation accuracy, and a high degree of visualization, effectively solving the pain point of higher radiation exposure from 2D X-ray fluoroscopy. According to VCBeat analysis, global 3D electrophysiology procedures have completely replaced 2D, accounting for over 80% of procedure volume.

The early localization methods for 3D systems were magnetic localization and electrical localization, both of which have high precision and can achieve real-time navigation, making the catheter visible and assisting doctors with navigation and decision-making. However, magnetic localization is highly sensitive to magnetic field interference and requires operation in an environment free from external magnetic field disturbances, while electrical localization may be affected by blood flow. Therefore,The 3D system gradually integrates both into a magnetic and electrical dual-positioning system, improving the accuracy of the positioning model while ensuring the precision and visualization of catheter positioning.

Johnson & Johnson's magnetic and electric dual-position mapping system, Carto 3, is a system that uses electromagnetic technology to generate real-time maps of a patient’s heart structure. Since its launch in 2009, it has become a benchmark in the electrophysiology mapping field and is also considered Johnson & Johnson's greatest advantage in surpassing other competitors in the PFA field in the future. Over the past 15 years, Johnson & Johnson has continuously upgraded the system to expand its lead. In May this year, Johnson & Johnson released the eighth upgraded version, "CARTO 3 V8," which, for the first time, uses AI to reconstruct the anatomy of the left atrium, eliminating the need for doctors to manually draw contours, thereby improving the efficiency of surgical workflows and the accuracy of the maps.

Currently, the PFA products of Jinjiang Electronics, Aikangmai, Huitai Medical, and Shangyang Medical all have magnetic and electrical dual positioning functions. At the same time, some companies are also developing innovative technologies in an effort to catch up.

Jianhu Medical's developed 3D dielectric mapping technology does not adopt the mainstream magnetic-electric dual positioning/magnetic-electric fusion technology. Instead, it achieves real-time 3D high-precision positioning and imaging of human tissue structures by measuring and tracking the changes in different dielectric constants of various types of tissue cells in the human body under the influence of an electric field.In May 2024, the Star Trek dielectric 3D mapping + nanosecond pulse ablation integrated system, developed by the company, completed the first interventional surgery in China for drug-refractory paroxysmal atrial fibrillation. In September, it completed clinical research for the treatment of persistent atrial fibrillation.

Xinhanglu Medicine Pioneers the "Four-Dimensional Cardiac Mapping System" DePolar Mapping System,Its most notable feature is that it seamlessly integrates magnetic-electric contact mapping technology with magnetic-electric non-contact mapping technology, both in technical development and clinical application, forming a unified mapping architecture. This system completed enrollment in July.

Pulsed electric field technology has evolved through three generations to date: the first generation of millisecond pulses, utilizing reversible electroporation effects for applications such as gene transfection, electroporation-based drug delivery, and electrochemical therapy; the second generation of microsecond pulses, leveraging irreversible electroporation effects for ablation treatments of tumors and arrhythmias like atrial fibrillation; and the third generation of nanosecond pulses, employing ultra-electroporation effects for intracavitary treatments in areas such as oncology, cardiovascular, respiratory interventions, and endoscopic interventions.

Nanosecond pulses, with the characteristics of high efficiency and low irritation, can address issues associated with existing PFA technology, such as high anesthesia requirements, muscle contractions, and patient pain, making PFA atrial fibrillation ablation procedures more efficient and safer.

According to publicly available information, companies currently possessing nanosecond pulse cardiac ablation products globally include Pulse Biosciences, Maiwei Medical, Beixing Medical, Jianhu Medical, and Ruidi Bio.

In July this year, Pulse Biosciences' CellFX nanosecond multi-electrode pulse ablation catheter received FDA Breakthrough Device Designation in July; Beixing Medical's Lotos PFA cardiac pulsed electric field ablation system also completed its first clinical enrollment; Jianhu Medical's nanosecond PFA integrated cardiac ablation system completed the clinical study for treating persistent atrial fibrillation in September; and Maiwei Medical's nsPFA nanosecond pulsed electric field ablation system completed clinical enrollment as early as August 2023.

It can be foreseen that China's PFA market will face exceptionally fierce competition in the future. However, amid the contest among various players, the ultimate beneficiaries will still be the patients.