Recently, Johnson&Johnson announced that it has received approval from the US Food and Drug Administration (FDA) for its Varipulse pulsed field ablation system, which can be used to treat drug-resistant paroxysmal atrial fibrillation. After obtaining approval, Johnson&Johnson became the third company in the United States to have PFA technology for treating AFib, joining the ranks of Medtronic and Boston Scientific, and the PFA market's top three competition officially opened.

With the support of an ace, Johnson&Johnson has strong competitive strength
It is understood that the Varipulse pulsed field ablation system consists of a Varipulse ablation catheter and a 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 LASSO catheter technology and further demonstrates Johnson&Johnson's deep technical reserves in the catheter field.

The Varipulse ablation catheter has 10 electrodes on the annular tip, and the size of the annular tip is adjustable (from 25 to 35mm). At the same time, the Varipulse ablation catheter can be bent in both directions, with one side bent 180 ° and the other side bent 90 °, making it suitable for four pulmonary veins, including the right inferior pulmonary vein. PFA is applied in a bipolar configuration between skipped electrodes (i.e. electrode 1 to electrode 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 microsecond long biphasic pulse sequences between all three bipolar configurations, with a total application duration of approximately 250 milliseconds.

In previous admIRE studies, the results of the Varipulse pulsed field ablation system were particularly impressive: the overall primary efficacy success rate was 75%, the peak primary efficacy of participants who received 73-96 P for PFA pulmonary vein isolation was 85%, the overall incidence of major adverse events was 2.9%, and no device or surgery related deaths, atrial esophageal fistula, coronary artery spasm, or hemolysis related renal failure requiring hemodialysis were reported.

It is worth noting that although the clinical data of Varipulse pulsed field ablation system is also considerable, Johnson&Johnson's Varipulse pulsed field ablation system alone is difficult to defeat Medtronic and Boston Scientific, which have already entered the PFA market ahead of Johnson&Johnson. Johnson&Johnson's true "trump card" is its latest AI cardiac mapping system, Carto 3, which is also the highest market share 3D mapping system.

Carto 3 features new modules including CARTO ELEVATE module and CARTOUND FAM module, aimed at improving the efficiency, reproducibility, and accuracy of catheter ablation procedures performed by electrophysiologists 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 achieves intuitive and replicable workflows through real-time visualization and feedback mechanisms.

Jasmina Brooks, President of Electrophysiology at Johnson&Johnson Medical, said, "With this approval, we are pleased 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 for seamless integration with the Carto 3 system, we believe this long-awaited platform will become a valuable tool for doctors to perform safe, effective, and efficient AFib surgeries with intuitive and repeatable workflows, as well as minimal or no fluoroscopy.

Three strong competition to accelerate the gap in mapping technology
Although Johnson&Johnson fell behind Medtronic and Boston Scientific by nearly a year before officially entering the PFA market, its powerful ace Carto 3 will also become a formidable competitor. This also sounds the alarm for Medtronic and Boston Scientific, accelerating the process of filling the gap in mapping technology.

On November 5th of this year, Boston Scientific announced a major acquisition, acquiring a mapping company called Cortex. The acquisition is expected to be completed in the first half of 2025. Cortex focuses 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 significant progress.

Cortex's OptiMap ™ The system obtained 510 (k) approval from the US Food and Drug Administration (FDA) in 2023 and recently completed a LOW-AF randomized controlled clinical trial. Data shows that compared to patients who only receive traditional pulmonary vein isolation treatment, the incidence of atrial fibrillation in patients with persistent atrial fibrillation decreased by 51% within one year after treatment ablation under the guidance of OptiMap. At the beginning of this year, Cortex launched a global clinical trial called RESOLVE-AF, involving 300 patients, aimed at evaluating the effectiveness of the OptiMap system in detecting atrial fibrillation triggers outside of the pulmonary vein.

And Affera, which Medtronic acquired for $1 billion in 2022, has also made significant progress this year. It has launched the Affera mapping and ablation system in the United States, which integrates three-dimensional mapping, radiofrequency ablation, and pulsed field ablation functions. The Affera mapping and ablation system is an integrated, dual energy pulsed field and radiofrequency ablation system with high-density mapping capabilities, used for cardiac electrophysiological ablation surgery. The system includes a mapping/ablation catheter (Sphere-9), an energy generator (capable of releasing PFA and RF), and a 3D mapping software (Prism-1).

Based on this, the Affera mapping and ablation system also has multiple advantages:
 RF/pulsed field ablation dual-mode: allows for intraoperative mode switching without the need to move the catheter and connecting wires, meeting the ablation needs of different parts.
 Lattice tip design: Sphere-9's lattice tip design (9 microelectrodes) 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, does not damage surrounding blood vessels and nerves, and does not cause damage to the esophageal and phrenic nerves; On the other hand, linear blockade can reach 100% in the acute phase, and the lesion remains continuous and translucent 35 days after surgery.
 Uniform and efficient delivery of electrical pulse energy: With a unique lattice tip design, it has a larger effective surface area and can deliver higher currents to tissues at lower current densities, increasing the safe and effective window for ablation. Its use in special areas such as ventricular myocardium has advantages.

Source: https://news.yaozh.com/archive/44532.html