Johnson & Johnson Launches Next-Gen PFA Platform Varipulse Pro in Europe with 5x Faster Ablation Speed

Fig. Varipulse Pro Next-Generation PFA Catheter

In 2025, Johnson & Johnson delivered strong financial results. The company achieved a total revenue of $94.2 billion for the year, representing a 6.0% increase year-over-year, with a net profit of $26.8 billion, marking a 90.5% year-over-year growth.The company expects its sales to exceed $100 billion by 2026. Of this, the medical technology segment is expected to generate $33.792 billion in revenue, representing a 6.1% increase. The cardiovascular department's sales grew by 15.8% year-on-year, making it the fastest-growing business segment. In the field of electrophysiology,Johnson & Johnson's Electrophysiology Sales Reach $5.634 Billion in 2025, with Only 7% Year-on-Year Growth。The financial report pointed out that this growth was mainly driven by the increase in surgeries within the integrated product portfolio, strong commercial execution, and the launch of new products such as Varipulse, but partially offset by competitive pressures in the PFA field.

PFA Technology Principle

Pulsed Field Ablation (PFA) is the most disruptive technological direction in the field of catheter ablation for atrial fibrillation (AF) in recent years.Pulse Field Ablation (PFA) creates irreversible electroporation on the myocardial cell membrane through high-voltage electrical pulses, inducing apoptosis. Unlike radiofrequency ablation, which relies on high temperatures, PFA is selective for myocardial cells — the electroporation threshold of myocardial cells is lower than that of surrounding tissues such as nerves, vascular endothelium, and the esophagus, theoretically reducing the risk of complications like phrenic nerve paralysis and atrioesophageal fistula.

Technological Breakthrough: Fivefold Ablation Speed and Ecological Synergy

The core improvement of Varipulse Pro lies in the pulse sequence. The new sequence offers an ablation speed five times faster than the previous generation, with a lower temperature curve and equivalent ablation effectiveness.Faster speed can shorten operation time and improve the turnover efficiency of the catheterization lab; lower temperature reduces the risk of thermal diffusion damaging surrounding tissues.Faster ablation speed means shorter operation time, less anesthesia exposure, and more efficient catheter lab turnover. As the global PFA market rapidly expands and the number of procedures surges, operational efficiency has become a key consideration for doctors and hospitals when choosing an ablation platform. The fivefold acceleration in efficiency could become a core differentiating advantage for Varipulse Pro in the highly competitive market.

The differentiated advantage of Varipulse Pro lies not only in its pulse sequence itself, but also in its deep integration with the Johnson & Johnson electrophysiology ecosystem. The system is seamlessly integrated with the Carto 3 three-dimensional mapping system, utilizing advanced positioning functions and tissue proximity indicators to achieve precise lesion delivery.

Carto 3 is one of the three-dimensional electrophysiology mapping systems with the highest global installed base, and has long been the core competitive advantage of Johnson & Johnson in the electrophysiology field. According to industry data, Johnson & Johnson has occupied approximately 50% of the electrophysiology market share in China for a long time, and the stickiness of the Carto system is an important barrier.The deep integration of Varipulse Pro with Carto 3 means that existing Carto users can directly upgrade to the new generation of PFA ablation without changing the mapping system, significantly reducing the learning curve for doctors and the technical switching costs for hospitals.

Clinical Evidence: Safety and Workflow Validation of the VARIPURE Study

The preliminary clinical cases of Varipulse Pro have been initiated in the VARIPURE study. VARIPURE is a prospective, multicenter, post-market follow-up study designed to evaluate the safety and effectiveness of the Varipulse platform in real-world settings.As of September 2025, the study has enrolled nearly 800 patients with atrial fibrillation, demonstrating robust safety data: a stroke incidence rate of 0, an acute pulmonary vein isolation (PVI) success rate of 99.7%, a major adverse event rate of only 0.6%, and no reports of coronary artery spasm or other PFA-related complications.

Workflow Validation：In February 2026, the workflow sub-study of the VARIPURE study was published in EP Europace. The study analyzed procedural data from 791 atrial fibrillation patients across 20 European centers and 62 operators, confirming that the PFA variable circular catheter enables efficient, safe, and reproducible ablation workflows.Among them, 24.3% of the patients received additional left atrial substrate ablation, primarily in PV-only isolation cases (69.9%), with ablation areas mostly targeting the posterior wall, roof, and anterior wall.. The study also analyzed the choice of sedation protocols (deep sedation vs. general anesthesia), providing a reference for clinical practice.Notably, the CARTONET AI-driven workflow analysis system was used in the study to automate the anatomical labeling of ablation points, assisting researchers in detailed analysis of ablation sequences, timing parameters, and adherence to standardized and optimized workflows.。

Figure 2.《EP Europace》Publishes the Workflow Sub-Study of the VARIPURE Study

12-Month Interim Results to Be Announced Soon

According to the official announcement from Johnson & Johnson, the 12-month interim results will be presented by Dr. Daniel Scherr at the EHRA PFA Summit. Previously, the VARIPURE study demonstrated safety data with a 0% stroke rate and a 99.7% acute PVI success rate among nearly 800 patients, and the 12-month results will validate long-term efficacy. Johnson & Johnson stated that it will continue to accumulate evidence through the VARIPURE study and other clinical research during the commercial launch period.

SMARTFIRE Study: 12-Month Effectiveness Data of the PFA Platform

The evidence base of the Varipulse platform is also supported by the SMARTFIRE study. This study was presented as a late-breaking trial at the 2025 EHRA congress, evaluating the 12-month efficacy and safety of the dual-energy THERMOCOOL SMARTTOUCH SF catheter in patients with drug-refractory symptomatic paroxysmal atrial fibrillation. The results showed that when using a high-adherence recommended ablation workflow, the 12-month efficacy reached 86.9%, quality of life improved clinically significantly, cardiovascular-related hospitalizations decreased by 40.8%, and the use of Class I/III antiarrhythmic drugs reduced by 60.4%. The rate of serious adverse device effects (SADE) was 3.6%, none of which were determined to be related to pulsed field energy.

Guidelines and Expert Consensus

PFA has been recognized by multiple authoritative guidelines:

• NICE Guidelines (July 2025)：The UK NICE officially released the IPG806 guideline, explicitly recommending PFA as the standard choice for atrial fibrillation treatment, based on a systematic review of 19 high-quality studies.

• HRS/EHRA Scientific Statement (February 2026)：The Heart Rhythm Society (HRS) and the European Heart Rhythm Association (EHRA) Release PFA Scientific Statement, Providing Comprehensive Guidance on Contemporary Scientific Knowledge, Appropriate Clinical Application, and Adverse Event Avoidance

Market Landscape: The Battle for Supremacy in the PFA Arena

The PFA track is becoming the most dynamic niche market in the electrophysiology field. According to Medtronic's forecast at the 2026 JPM conference, the PFA market size exceeds 13 billion USD, with an annual growth rate of over 25%. It is expected that by 2028, the PFA penetration rate will increase to 80%.

At present, the competitive landscape of the PFA track has basically taken shape, with all major giants having entered the market:

• Boston Scientific (Farapulse)：A Pioneer in the PFA Field. Boston Scientific acquired this technology through the 2021 acquisition of Farapulse, establishing a large installed base with its first-mover advantage. In the third quarter of 2025, sales of its electrophysiology business increased by 63% year-over-year, while Farapulse's growth in the U.S. market reached 117%. By 2025, the product had treated over 500,000 patients, and Boston Scientific expects global PFA penetration to reach 50% by the end of 2025.

• Medtronic (PulseSelect)：The world's first PFA product to simultaneously receive CE, FDA, Japanese regulatory, and NMPA approval. By 2025, PulseSelect achieved over 300% growth in both the U.S. and overseas markets, driving a 71% increase in the cardiac ablation solutions business. Medtronic forecasts that by the end of fiscal year 2026, cumulative revenue from its PFA products will exceed $1 billion, becoming the second PFA product to reach this sales milestone.

• Abbott (Volt)：Received CE certification in March 2025 and officially entered the European market. The Volt PFA System was approved based on positive results from its Volt CE Mark study and is currently expanding clinical applications worldwide.

• Kardium (Globe), CardioFocus (Centauri), MicroPort EP (PulseMagic)：The aforementioned products have either obtained CE certification in Europe or are in the process of doing so, forming the second tier in the PFA race.

Against the backdrop of the full commercialization of PFA, surgical efficiency and clinical evidence have become the core dimensions of competition. Boston Scientific takes the lead with its first-mover advantage, Medtronic quickly catches up through multi-market deployment, Abbott joins the competition starting with CE certification, while Johnson & Johnson attempts to break through the competition by leveraging the efficiency advantages of its Carto ecosystem and Varipulse Pro.

The PFA track is moving from "technical feasibility" to "full commercialization," and the launch of Varipulse Pro represents Johnson & Johnson's strategic positioning in the PFA field. By increasing ablation speed by five times, Varipulse Pro not only strengthens the stickiness of Johnson & Johnson’s existing Carto user base but also provides a more attractive efficiency advantage for acquiring new users. With the release of 12-month interim data and clinical presentations at the EHRA conference, Varipulse Pro is expected to carve out a differentiated space in the highly competitive PFA market.

Future Outlook: On-site Validation of EHRA 2026

The 2026 European Heart Rhythm Association (EHRA) Annual Meeting is set to take place in Paris. Johnson & Johnson plans to highlight the Varipulse Pro platform at the EHRA Annual Meeting, featuring live surgical demonstrations, hands-on training, and professional educational courses. Additionally, Dr. Daniel Scherr will present the 12-month interim results of the VARIPURE study at the EHRA PFA Summit.

For clinicians, the EHRA conference provides a window to visually assess the operational performance and clinical outcomes of Varipulse Pro; for investors and industry observers, the 12-month data from the VARIPURE study will validate the safety and efficacy of Varipulse Pro in real-world settings, offering critical evidence for its subsequent registration and market access in more regions.

Varipulse Pro is still in the research phase in the United States and has not yet received FDA approval. This European launch marks an important step in Johnson & Johnson's global strategy for its PFA product portfolio, while also accumulating clinical data and commercialization experience for subsequent promotion in the U.S. market. As PFA technology continues to evolve and market penetration increases, competition in the electrophysiology field will enter a new phase — shifting from "who can perform PFA" to "who can do it faster, safer, and more precisely."