On September 10, the National Medical Products Administration (NMPA) issued a statement:The National Medical Products Administration has approved Medtronic's "Cardiac Pulsed Field Ablation System" and "Single-Use Cardiac Pulsed Field Ablation Catheter"Two innovative product registration applications."
Used in conjunction, the two products leverage the non-thermal effects of pulsed electric fields to treat drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillation or drug-refractory, recurrent, symptomatic persistent atrial fibrillation (with episodes lasting less than one year). Compared with traditional radiofrequency ablation and cryoablation products, this product achieves selective destruction of myocardial tissue, avoiding the risk of damage to surrounding tissues caused by heat transfer.
PulseSelect Pulsed Field Ablation System
Medtronic'sPulseSelectPulse Field Ablation System in2018Year received approval in the United StatesFDAThe“Breakthrough Medical Device”Identification, in2020Year1Month ObtainedFDAResearch Device Exemption (IDE) to conduct clinical trials,2023Year11Month ObtainedCEApproval,2023Year12Month received U.S.FDAApproval.2024Year5Month10Medtronic Receives Regulatory Approval in JapanIt has now been approved in China,Expand the treatment technology for patients with paroxysmal and persistent atrial fibrillation, which has been proven safe and effective, to a global scale.
Recently, there has been a series of positive developments in the pulsed field ablation sector. Not long ago, another international giant, Boston Scientific,Pulsed Field AblationThe product also received regulatory approval, marking a golden age of vigorous development for the industry.
Pulsed Field Ablation, also known as irreversible electroporation, is electric field-dependent, generates no local heat, has strong penetration ability, and offers long-lasting effects. It effectively addresses the "zero-sum effect" issue of thermal ablation, receiving positive evaluations in clinical studies and is expected to become a new option for catheter ablation in atrial fibrillation.
In order to promote the development of pulsed electric field ablation technology in China, the Medical Device Innovation Network has carefully collected information from several internationally renowned enterprises.Pulsed Field AblationCatheter products, through preliminary morphological analysis, it was found that these catheters are ingeniously designed with various shapes.With both the soft beauty of blooming flowers and the technological feel of rings or globes, as well as creative designs like baskets and balloons, they exhibit a high degree of personalization and innovation. Currently, there is no unified standard shape.These design highlights are now organized and presented, aiming to provide inspiration and reference for peers in China, and to jointly promote the innovation and advancement of pulsed electric field ablation technology.
Catheter Shapes Are Myriad
Medtronic PulseSelect, Affera Sphere-9, 360The previously mentioned PulseSelect features a nitinol superstructure, and its catheter adopts a proprietary biphasic waveform, a unique built-in online design, and a 20-degree forward tilt. It requires an average total energy delivery time of just 30 seconds to complete pulmonary vein isolation, making the procedure simpler and faster.Medtronic is also advancing the pulsed field ablation catheter developed by Affera, the Affera Medtronic AfferaSphere-9 and Sphere360.Both the Sphere-9 and Sphere-360 catheters are made of nickel-titanium alloy and are highly compliant. When pressed against cardiac tissue, they bend to conform to the shape of the pulmonary veins, allowing for better contact and more effective ablation as a single spherical electrode for delivering ablation energy.When Sphere-9 is released from the catheter inside the patient's heart, it inflates into a spherical shape for localized ablation.Sphere-360 is a single-injection catheter that can be adjusted into various shapes, including spherical, oval, etc., with a maximum diameter of 34 millimeters in the shape of a pancake.Currently, the Sphere-9 device is under review by the FDA.Boston Scientific FarapulseFarapulse Pulsed Field Ablation System
Farapulse is the second pulse field ablation system to receive FDA approval for the treatment of atrial fibrillation. The distal end of its ablation catheter features a unique flower-shaped design with a total of five "petals," each equipped with four electrodes. A slider button on the handle controls whether the distal end forms a "bud" or a "fully bloomed flower." When all five "petals" are fully open, they form a flat, petal-like shape; when partially expanded, they create a three-dimensional basket shape, with the basket diameter adjustable via catheter extension and retraction.In January 2021, the FARAPULSE system received CE certification, becoming the first to obtain CE certification.Pulsed Field AblationSystem,In January 2024, it received FDA approval for the treatment of drug-refractory, recurrent, symptomatic, paroxysmal (i.e., intermittent) atrial fibrillation. Since then, Boston Scientific has been aggressively promoting the system in the European market. Globally, more than 40,000 patients have already been treated with the system, establishing a solid market foundation.It was approved by the National Medical Products Administration in July 2024.Volt Pulsed Electric Field Ablation
The Volt pulsed electric field ablation catheter is a balloon basket type, consisting of outward-facing electrodes and flat rather than round insulated nitinol strips. It is a hybrid catheter that can be used for both single-shot ablation and focal ablation.The balloon acts as an insulator within the blood, reducing the incidence of thermal effects such as hemolysis and bubble formation. It also helps stabilize the basket within the pulmonary vein, positions the catheter at the ablation target site, applies energy, and slightly rotates the device to achieve spline offset for a second ablation.Abbott is testing the Volt system under the FDA's Investigational Device Exemption and expects to gain European approval in the form of a CE mark by 2025.Johnson & Johnson VARIPULSEBiosense Webster Varipulse Pulsed Field AblationThe Varipulse catheter features a circular design, with an adjustable range of 25mm to 35mm. The catheter is made from laser-cut nitinol, allowing it to form an adjustable and retractable loop. This helps ensure sufficient tissue contact across different cardiac anatomies and makes it easier to maneuver the catheter within the confined space of the left atrium. The 10 electrodes can deliver treatment simultaneously in a single shot, or alternatively, only 6 electrodes can be used to provide more focused energy, combining the best attributes of both approaches.Varipulse obtained the CE mark for its catheter in February 2024 and applied for FDA approval in March.Johnson & Johnson's pulsed field ablation product, the VARIPULSE system, was approved for marketing in Japan in January 2024. In addition, Johnson & Johnson has developed two other pulsed field ablation catheters: Omnypulse and THERMOCOOL SMARTTOUCH™ SFF.Omnypulse is a product that can be integrated with Carto3.Pulse Field AblationAblation catheter, whose distal end features an expandable design that can expand up to 12mm. It provides tactile feedback and enhanced mapping capabilities, and is compatible with the Trupulse energy platform to deliver Trupulse bipolar biphasic pulse energy during cardiac ablation procedures.The THERMOCOOL SMARTTOUCH™ SF catheter is characterized by dual-energy capability, allowing for switching between radiofrequency and pulsed field energy to customize treatment. This dual-energy design simplifies the workflow of ablation procedures.Omnypulse Catheter (Left),
THERMOCOOL SMARTTOUCH™ SF Catheter (Right)
Chinese Companies Are Poised for Action
Currently, the electrophysiology market in China has enormous potential, with an electrophysiology procedure penetration rate of less than 1%, indicating vast room for development; in China's cardiac electrophysiology market, domestically produced brands account for less than 10% of the market share, presenting significant opportunities for domestic substitution.Approved in ChinaPulsed Field AblationProduct:
Relevant data shows that in 2022, radiofrequency ablation accounted for 88% and cryoablation accounted for 12% of atrial fibrillation ablation procedures in China. It is expected that pulsed field ablation will be commercialized in China within two years. By 2028, the number of atrial fibrillation ablation procedures in China is projected to reach 590,000 cases, with pulsed field ablation accounting for approximately 9%.According to Frost & Sullivan's forecast, ChinaPulsed Field AblationThe market size will reach 1.3 billion yuan by 2025 and maintain rapid growth, expected to reach 16.3 billion yuan by 2032.The compound annual growth rate during the period is43.73%. The proportion of China's pulsed field ablation market size in the overall electrophysiology device market size is predicted to beThe proportion will continue to rise, increasing from 8.18% in 2025 to 38.87% in 2032.Medical Device Innovation Network has compiled a simple overview of 10 local pulse field ablation companies for reference only.Medical Device Innovation Network MappingWith the intensification of China's aging population trend and the rise in the incidence of cardiovascular diseases, the field of cardiac electrophysiology surgeries is witnessing a continuously growing market demand. Pulsed field ablation technology, as a novel ablation tool in the cardiac electrophysiology sector, is expected to occupy a central position in the future market due to its unique advantages, particularly in the treatment of arrhythmia conditions such as atrial fibrillation.Pulse Field AblationIs expected to become one of the mainstream treatment methods.To stimulate the innovative vitality and sustainable development of the medical device industry,The Chinese government has actively introduced a series of support policies, strongly supporting the research and development and market promotion of domestically produced medical devices, forPulsed Field Ablation...and other cutting-edge technologies have paved a solid path for growth.At the same time, the increasingly improved medical insurance system and the enhancement of patients' payment ability will further broadenPulse Field AblationThe market accessibility of technology benefits more patients.Facing fierce competition from domestic and international medical device companies and the continuous influx of new entrants,Pulse Field AblationThe market landscape is undergoing profound changes. Companies in China need to continuously increase investment in technological innovation and product development, optimize product performance and quality, in order to stabilize and expand their market share in the fierce market competition. In addition, strengthening marketing strategies and brand building, and enhancing brand influence and reputation, are also important directions that companies in China cannot ignore.Particularly noteworthy is that the field of atrial fibrillation treatment still faces many challenges, and the treatment of patients with persistent and long-standing persistent atrial fibrillation is especially complex in China.Pulsed Electric FieldManufacturers are gradually aligning with international standards, and the protection of intellectual property and innovation in research and development will become the focus of the industry. The Medical Device Innovation Network will continue to monitor the future R&D trends and patent layouts of related products and provide you with reports.Further Reading: What is Pulsed Field Ablation?
Ablation technology encompasses various methods, mainly including radiofrequency ablation, cryoablation, and the emerging pulsed electric field ablation.Radiofrequency Ablation: The Use of Radiofrequency Current to Eliminate Abnormal Cardiac Muscle Cells at Specific Sites. Cold Saline-infused Ablation Catheters Utilize Low-temperature Saline to Cool the Catheter Tip During Ablation, Reducing the Temperature of the Electrode Tip. This Allows for High-frequency Discharge While Preventing Excessive Tissue Interface Temperature, Enhancing Surgical Safety, Reducing Severe Complications Such as Thrombosis, and Minimizing Patient Discomfort.Cryoballoon ablation absorbs heat through the evaporation of liquid refrigerant inside the balloon, causing a sudden drop in temperature around the ablation target. This cold temperature damages or kills abnormal myocardial cells in the area. Compared to radiofrequency ablation, cryoballoon ablation has the advantages of relatively simpler procedure, shorter learning curve, and good result reproducibility.Pulsed Electric Field Ablation, also known as irreversible electroporation, refers to the application of high-voltage electric pulses to the phospholipid bilayer of the cell membrane over a short period, leading to the formation of transmembrane potential and unstable electric potential. This results in irreversible penetrative damage to the cell membrane, creating nanoscale pores, which subsequently alter cell membrane permeability, disrupt intracellular homeostasis, and ultimately cause apoptosis, achieving non-thermal ablation. Previously, electroporation ablation was used as an effective method for destroying malignant tumor tissues, and its application in atrial fibrillation ablation has gradually become a research hotspot in recent years.
