Recently, Johnson & Johnson announced that it has obtained approval from the U.S. Food and Drug Administration (FDA) for its Varipulse pulsed field ablation system for the treatment of drug-refractory paroxysmal atrial fibrillation. After obtaining approval, Johnson & Johnson became the third company in the United States to have PFA technology for the treatment of AFib, joining the ranks of Medtronic and Boston Scientific, and the three-way competition in the PFA market has officially begun.

It is understood that the Varipulse pulsed field ablation system consists of the Varipulse ablation catheter and the TRUPULSE generator. Among them, the VARIPULSE ablation catheter was developed based on Johnson & Johnson's previous mapping catheter LASSO catheter, which is a continuation of the LASSO catheter technology, which further demonstrates Johnson & Johnson's deep technical reserves in the catheter field.

The Varipulse ablation catheter has 10 electrodes on the ring tip, and the ring tip size is adjustable (from 25 to 35mm). At the same time, the Varipulse ablation catheter can be bent bidirectionally, 180° on one side and 90° on the other side, so it can be applied to four pulmonary veins, including the right inferior pulmonary vein. PFA is applied in a bipolar configuration between the skipped electrodes (i.e., electrodes 1 to 3) and between each adjacent electrode between them (i.e., electrodes 1-2 and 2-3), with an energy of 1800 V. Each PFA application includes a microsecond-long biphasic pulse sequence between all 3 bipolar configurations, with a total application duration of approximately 250 milliseconds.

In the previous admIRE study, the results of the Varipulse pulsed field ablation system were also particularly impressive: the overall primary effectiveness success rate was 75%, the peak primary effectiveness of participants who received 73-96 Ps for PFA pulmonary vein isolation was 85%, the overall incidence of major adverse events was 2.9%, and no device- or procedure-related deaths, atrioesophageal fistulas, coronary artery spasms, or hemolysis-related renal failure events requiring hemodialysis were reported.

It is worth noting that although the clinical data of the Varipulse pulsed field ablation system is also quite impressive, it is difficult for Johnson & Johnson to defeat Medtronic and Boston Scientific, which have entered the PFA market one step ahead of Johnson & Johnson, with the Varipulse pulsed field ablation system alone. Johnson & Johnson's real "killer weapon" is its latest AI cardiac mapping system, Carto 3, which is already on the market. This system is also the three-dimensional mapping system with the highest market share.

Carto 3 has new modules including the CARTO ELEVATE module and the CARTOUND FAM module, which are designed to improve the efficiency, reproducibility and accuracy of electrophysiologists performing catheter ablation procedures to treat patients with atrial fibrillation and other arrhythmias. The Varipulse pulsed field ablation system is the first and only PFA technology integrated with Carto 3, which is perfectly compatible with Carto 3 and enables intuitive and reproducible workflows through real-time visualization and feedback mechanisms.

Jasmina Brooks, President of Johnson & Johnson Medical Electrophysiology, said: "With this approval, we are excited to bring the Varipulse platform to electrophysiologists and patients in the United States, where AFib affects nearly 8 million people. As the only unique PFA platform designed to seamlessly integrate with the Carto 3 system, we believe this long-awaited platform will become a valuable tool for physicians to perform safe, effective and efficient AFib procedures with intuitive and repeatable workflows and minimal to no fluoroscopy."

Although Johnson & Johnson officially entered the PFA market nearly a year behind Medtronic and Boston Scientific, it will also become a rival that cannot be underestimated with its powerful trump card Carto 3. This also sounded the alarm for Medtronic and Boston Scientific to accelerate the process of filling the gap in mapping technology.

On November 5 this year, Boston Scientific announced a blockbuster acquisition of Cortex, a mapping company, and the acquisition is expected to be completed in the first half of 2025. Cortex is focused on developing an integrated platform for comprehensive mapping and ablation for the treatment of atrial fibrillation (AFib). Although it is still a young company, its products have made great progress.

Cortex's OptiMap™ system received 510(k) clearance from the U.S. Food and Drug Administration (FDA) in 2023 and recently completed the FLOW-AF randomized controlled clinical trial. Data showed that the incidence of atrial fibrillation within one year after ablation of patients with persistent atrial fibrillation under the guidance of OptiMap was reduced by 51% compared with patients who only received traditional pulmonary vein isolation treatment. Earlier this year, Cortex launched a global clinical trial called RESOLVE-AF, which involved 300 patients and aims to evaluate the effectiveness of the OptiMap system in detecting atrial fibrillation triggers outside the pulmonary veins.

Affera, which Medtronic acquired for $1 billion in 2022, also made significant progress this year. It launched the Affera mapping and ablation system in the United States, which integrates three-dimensional mapping, radiofrequency ablation, and pulsed field ablation. The Affera mapping and ablation system is an integrated, dual-energy pulsed field and radiofrequency ablation system with high-density mapping capabilities for cardiac electrophysiological ablation procedures. The system includes a mapping/ablation catheter (Sphere-9), an energy generator (capable of releasing PFA and RF), and a three-dimensional mapping software (Prism-1). Based on this, the Affera mapping and ablation system also has multiple advantages: Radiofrequency/pulsed field ablation dual mode: allows mode switching during surgery without moving the catheter and connecting wires, which can meet the ablation needs of different parts.

Lattice tip design: The lattice tip design (9 microelectrodes) of Sphere-9 can provide point ablation and can also be flexibly used in different anatomical locations, such as linear lesions. It has higher safety and effectiveness: on the one hand, it selectively affects myocardial cells without damaging surrounding blood vessels and nerves, and there is no damage to the esophagus and phrenic nerves; on the other hand, it can achieve 100% linear block in the acute phase, and the lesion 35 days after surgery still shows continuous transmural properties.

Uniform and efficient delivery of electrical pulse energy: The unique lattice tip design has a larger effective surface area, can deliver higher current to tissues at a lower current density, increase the safe and effective window for ablation, and has advantages in use in special parts such as ventricular myocardium. So far, the three-way competition for PFA has been officially established. Although Johnson & Johnson has the trump card of Carto 3, it still cannot be taken lightly. In the subsequent development, Johnson & Johnson may use "all its tricks" in research and development innovation to compete with Medtronic and Boston Scientific for the position of PFA hegemony.

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