
J&J reviews 12-month knowledge for the Varipulse PFA platform
Johnson & Johnson (J&J) has reported 12-month interim outcomes from the VARIPURE trial, assessing the effectiveness and security of its Varipulse pulsed subject ablation (PFA) platform in new customers.
The findings had been unveiled on the 2026 annual assembly of the European Coronary heart Rhythm Affiliation (EHRA) in Paris, France, and printed in Europace.
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Extra data
At 12 months, the research reported that 84.2% of sufferers had been freed from all documented recurrences of atrial arrhythmia, with 90.5% of sufferers experiencing paroxysmal atrial fibrillation (AFib) and 75.3% of persistent instances.
These charges are based mostly on Kaplan-Meier estimates. The protection profile confirmed a main adversarial occasion (PAE) charge of 0.8% and no incidence of stroke, coronary spasm or different PFA-related issues.
The total research cohort consists of 1,023 sufferers from 22 websites in Europe, of which 442 accomplished 12 months of follow-up on the time of research.
Moreover, 29.7% of contributors underwent non-pulmonary vein ablation procedures, highlighting the flexibleness of the Varipulse platform.
Gregory Michaud, chief medical and scientific officer of electrophysiology at J&J, stated: “Varipure represents a big step ahead within the evolution of pulsed subject ablation, demonstrating robust leads to an actual scientific setting as Varipulse’s use will increase.
“The observations in persistent AFib sufferers, together with significant experiences past pulmonary vein isolation, converse to the flexibility of the platform for a variety of affected person sorts and ablation methods.
“A continued dedication to rigorous proof era and deep scientific experience will additional elevate the usual of look after sufferers with AFib and sophisticated arrhythmias.”
J&J additionally confirmed that the Varipulse catheter has obtained an up to date CE mark, permitting ablation exterior the pulmonary veins in Europe, following approval by German certification firm DEKRA. This regulatory change allows expanded workflows for the therapy of refractory AFib and displays the rising scientific assist for the platform.
The Varipulse platform consists of the Varipulse catheter, Trupulse generator, Carto 3 mapping system and Varipulse software program.
Earlier this month, J&J launched Varipulse Professional in Europe after receiving CE marking, strengthening its PFA portfolio.