Biosense Webster, part of Johnson & Johnson MedTech, has reported 12-month results from the inspIRE and admIRE trials demonstrating month freedom from atrial arrhythmia recurrence in 80% of the patients with the use of the Varipulse platform.
Varipulse platform consists of an integrated variable-loop multielectrode catheter along, a multichannel pulsed field ablation generator, Trupulse generator, and a 3D cardiac mapping system, Carto 3 system Varipulse service pack software.
In January, the system was approved for the treatment of drug-refractory recurrent paroxysmal atrial fibrillation (PAF) by the Japan Ministry of Health, Labour and Welfare. In Europe, whilst the Trupulse generator has received a CE mark, Varipulse catheter has not. In the US, both the Trupulse generator and Varipulse catheter have not been approved by the Food and Drug Administration (FDA).
The multicentre study of the treatment of PAF by pulsed field ablation system with irreversible electroporation (inspIRE trial – NCT04524364) enrolled patients with drug-refractory PAF. The study ran from March 2021 to May 2022 across Canada and Europe. Of the 186 patients, 75.6% achieved the primary endpoint of acute pulmonary vein isolation and 12-month freedom from atrial arrhythmia recurrence.
The company added that 80% of the patients who received optimal pulsed field ablation achieved the primary endpoint. Additionally, the study reported a fluoroscopy time of 7.8 minutes and a primary adverse event rate of 0.0%.
The prospective admIRE trial (NCT05293639) evaluated the safety and long-term effectiveness of the Varipulse Platform when used for the isolation of pulmonary veins in the treatment of patients in the US with symptomatic drug refractory PAF. Of the 20 patients enrolled in the trial 100% achieved acute success from ablation procedures and 80% remained free from atrial arrhythmia recurrence at one year.
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Furthermore, no procedure or device-related primary adverse events were reported. The median procedure and fluoroscopy times were 90.0 and 3.5 minutes, respectively.
The cardiac ablation market, especially the electrophysiology ablation catheter landscape has seen significant advancements in recent years. In December 2023, Medtronic received US FDA approval for its pulsed field ablation system, PulseSelect, making this the first pulsed field ablation catheter to be commercially available in the US. A month following that, Boston Scientific secured FDA approval for its Farapulse system.
As per GlobalData analysis, the three companies currently dominate a specific geographic region in the pulsed field ablation space: Medtronic in North America, Boston Scientific in Europe, and Johnson & Johnson in Asia.