Source of the article: Heart Future; Editor: Li YuanmingReprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.
On January 27, 2025, the National Medical Products Administration approvedJohnson & Johnson Subsidiary——Biosense Webster, Inc.TheCardiac Pulsed Field Ablation System(National Medical Device Registration Import 20253010069) andSingle-Use Magnetic Navigation Cardiac Pulse Field Ablation Catheter(China Medical Device Registration No. 20253010070)Two innovative product registration applications.
Varipulse System byVaripulse Ablation CatheterAndTruPulse GeneratorComposition,In order to stand out in a highly competitive market, it is also fully compatible with Johnson & Johnson's Carto 3 three-dimensional mapping system. AsThe First Integrated Pulse Field Ablation Technology with Carto 3Varipulse achieves the intuitiveness and repeatability of operational procedures through real-time visualization and feedback.This system is mainly used for treatment.Drug-refractory, recurrent, symptomatic paroxysmal atrial fibrillationUtilizing the non-thermal effect principle of pulsed electric fields for atrial fibrillation treatment, it achieves selective destruction of myocardial tissue compared to traditional radiofrequency ablation and cryoablation products, avoiding the risk of surrounding tissue damage caused by temperature transfer.Varipulse SystemInEntered the innovation channel in February 2021, subsequentlyHave been respectively onApproved by Japan PDMA in January 2024, EU CE in February 2024, US FDA in November 2024, and China NMPA in January 2025., has been successfully applied in over 3000 surgeries worldwide, and has received "2024 Global Medical Technology Innovation Award”。Varipulse Ablation Catheter is Johnson & Johnson's previous mapping catheter.Lasso CatheterDeveloped on the basis of previous work, it is a continuation of the Lasso catheter technology.The ablation catheter inWith 10 electrodes on the circular tip, and the size of the annular head is adjustable (from 25 to 35mm).At the same time, the catheter can be bidirectionally deflected, with one side deflecting 180° and the other side deflecting 90°.Therefore, it can be applied to four pulmonary veins., including the right inferior pulmonary vein.TruPulse Generator in the Treatment of Cardiac ArrhythmiasProvide reliable power transmission, used to generate pulsed fields within the heart for precise ablation treatment of cardiac tissue. Its energy control and modulation functions allow customized treatment according to the doctor’s needs, thereby improving treatment efficacy and safety.In the previous admIRE study, among 277 patients with paroxysmal atrial fibrillation (PAF) at 33 centers in the United States,AcuteThe success rate of pulmonary vein isolation (PVI) was 100%, the first-time isolation success rate was 97.5%, and the achievement rate of the primary effectiveness endpoint was 74.6%.The operation, fluoroscopy, and PFA application times were shorter, with a low incidence of major adverse events (<3%). No device- or procedure-related deaths, atrial-esophageal fistulas, coronary artery spasms, or hemodialysis-requiring renal failure associated with hemolysis were reported.
But it is difficult for Johnson & Johnson to defeat Medtronic and Boston Scientific, which have already entered the PFA market ahead of Johnson & Johnson, solely relying on the Varipulse pulsed field ablation system.Johnson & Johnson's real "trump card" is its marketed three-dimensional cardiac mapping system——Carto 3, which is also the 3D mapping system with the highest market share.
The advancement of Carto 3 is key for Johnson & Johnson to surpass competitors in the PFA field, itsCapable of providing 3D images of cardiac anatomy and real-time electrical activity., helping doctors minimize or even completely avoid the use of X-ray fluoroscopy during surgery. Combined with intracardiac ultrasound tools, it further reduces radiation exposure for both patients and medical staff. In addition, the system supports access to the interior of the heart through a single transseptal puncture site, simplifying the surgical process and eliminating the need for frequent catheter changes.
# Safety still needs continuous attentionNotably, on January 8, 2025, Johnson & Johnson announced that due to four reported neurovascular events during an external evaluation, and out of caution,Will suspend the use of its newly launched Varipulse pulsed field ablation system in the United States., and began investigating the root causes of these neurovascular events.Due to the unique platform and configuration adopted for external clinical evaluations in the United States,VARIPULSE™ Clinical Use Outside the United StatesNo impact on bed applications and commercial sales。”
Currently, Johnson & Johnson is actively completing the investigation according to medical safety procedures, summarizing and optimizing existing processes, in order to restart the external clinical evaluation process and subsequent clinical applications.There is currently no product recall of any kind in the U.S. market., and the company will share more information if there is any further update.
In fact, in the development process of electrophysiology,Pulse technology, compared to radiofrequency technology, is still in its infancy, and safety experience and data require more clinical evidence and long-term patient follow-up validation.From the FDA's adverse event database MAUDE, it can be seen that safety events in the clinical use of pulsed ablation are not uncommon.
Recently, a study on the safety of pulsed ablation technology was published in the "Journal of Interventional Cardiac Electrophysiology," providing insights intoMedtronic PulseSelect™ and Boston Scientific FARAPULSE™Latest Safety Analysis of Two Pulse Ablation Systems. This study, based on the FDA's MAUDE database, analyzed all adverse event reports from the time of FDA approval up to June 13, 2024.
Research shows that the PulseSelect™ system between March 8, 2024, and May 30, 2024A total of 31 adverse events were reported.，The FARAPULSE™ system reported 319 incidents between February 6 and May 30, 2024., including patient-related events such as air embolism, pericardial effusion, hemolysis/acute kidney injury, and vasospasm, among others. Additionally, there have been some reported fatalities.
Although pulsed field ablation offers a new option for treating atrial fibrillation,But its safety still needs continuous attention.. The safety of pulsed ablation surgery is a complex issue that requires more clinical practice and scientific research to explore optimized solutions that are safer and more effective for patients with atrial fibrillation.
# How Competitive is PFA?The global PFA market was valued at US$105 million in 2023 (according to Roots Analysis data),It is expected to reach 5.5 billion US dollars by 2035（2024-2035 CAGR=39.1%），High growth is mainly driven by technology upgrades, increased penetration rates, and the expansion of indications.As of the end of 2024, the FDA has approved a total of five products from three manufacturers (Medtronic, Boston Scientific, Johnson & Johnson), which have already started to see a steep increase in adoption.In 2024, the proportion of PFA in atrial fibrillation surgeries in the United States will reach approximately 20%.(In the first year of commercialization), Boston Scientific's products are expected to increase by at least 40-60% by 2026 (thanks to favorable medical insurance reimbursement and anesthesia support).
▲Approval Progress of PFA Products from the Three Major Foreign GiantsBoston ScientificTheFARAPULSE SystemAsThe World's First Commercialized PFA Product, obtained the EU CE certification in January 2021, followed by the U.S. FDA, China NMPA, and Japan PDMA market approvals in January, July, and September 2024, respectively.Driven by the continuous growth of the FARAPULSE system in global core markets, the company's electrophysiology business revenue has achieved rapid growth.(According to the company's announcement, the revenue from the electrophysiology business in the third quarter increased by 177% year-on-year). At the same time, the company continues to iterate its products.New-generation catheter with 3D mapping functionFARAWAVE NAVObtained FDA registration certification in the United States in October 2024.MedtronicThePulseSelect SystemThe product has received marketing approval from the EU CE in November 2023, the US FDA in December 2023, Japan's PDMA in May 2024, and China's NMPA in September 2024. Notably, this product has taken the lead over FARAPULSE to become...The First PFA Product Launched in the U.S. Market, becoming a landmark event in its commercialization process. Meanwhile, another PFA product from MedtronicSphere-9 and its配套使用的Affera Mapping and Ablation SystemIt also received EU CE approval in March 2023 and U.S. FDA approval in October 2024, making the company the first in the industry to provide patients with two PFA clinical technology pathways.Johnson & JohnsonExceptOutside the Varipulse system,Johnson & Johnson is also actively advancing the development of its ThermoCool SmartTouch SF catheter and Omnypulse catheter. The ThermoCool SmartTouch SF catheter is a dual-energy catheter that combines "PFA + radiofrequency," while the Omnypulse catheter features an expandable basket design and integrates pressure monitoring with enhanced 3D mapping capabilities.AbbottThe PFA development progress is slower than the above three companies, and its first PFA productVolt SystemAchieved the first clinical application in January 2024, andComplete Global IDE Registration Clinical Trial Enrollment 4 Months Ahead of Schedule in October 2024The system adopts a spherical ablation catheter tip design, which can effectively contact the target tissue during the ablation process. It is expected to receive FDA approval for market release in the United States between 2027-2028. In addition, the company has also initiated global clinical trials for the TactiFlex "PFA + Radiofrequency" dual-energy ablation catheter, and the successive product launches may bring new momentum to the development of the industry.In addition, CardioFocus's Centauri system has received EU CE certification, and multiple PFA products are actively advancing in the R&D process, such as Kardium's Globe PF and Adagio Medical's CryoPulse.
▲Introduction to Representative PFA Products OverseasAs of the end of 2024,In China, the PFA market has approved products from 2 imported brands (Boston Scientific, Medtronic) and 3 domestically produced brands (Jinjiang Electronics, Denovo Electrophysiology, HT Medical)., the progress of Chinese brands is relatively slightly ahead. There are also many manufacturers in the research and development stage, mainly including MicroPort EP (the PFA of its invested company Shangyang Medical has submitted a registration application, and its self-developed PFA has completed clinical enrollment; the company expects both to be approved by 2025), XuanYu Medical (has submitted a registration application), Johnson & Johnson (has submitted a registration application), etc., andSeveral products have completed clinical enrollment or have submitted registration applications, with bulk approvals expected in 2025-2026.Among the five approved companies, the products of Jinjiang Electronics and Denovo Electrophysiology have been mass-introduced into top hospitals in multiple provinces and cities across China, with positive clinical evaluations. The products of Boston Scientific and Medtronic, which were approved later, are also gradually completing pricing and listing processes, and are successively being used clinically in China. In terms of indications, among the five approved companies,Only Medtronic's PulseSelect product has both paroxysmal atrial fibrillation and persistent atrial fibrillation indications (the other four companies only have paroxysmal atrial fibrillation indications).
▲Major P in ChinaFA Product Progress Product
Biosense Webster is a company with significant influence in the field of cardiac electrophysiology, and its products and technologies are widely used in the diagnosis and treatment of arrhythmias.The company isJohnson & JohnsonThe cardiac electrophysiology brand under the company provides including3D Cardiac Electrophysiology Mapping System, Electrophysiology Mapping Catheter, Radiofrequency Ablation CatheterAnd other products.In 1996, Johnson & Johnson acquired Cordis Webster and Biosense for $1.8 billion and $400 million, respectively, and merged the two to establish Biosense Webster, which is now responsible for Johnson & Johnson's electrophysiology business. It is dedicated to researching and developing electrophysiology interventional diagnosis and treatment products, providing comprehensive solutions for arrhythmia diseases to physicians and patients.
