“Out of an abundance of caution,” Johnson & Johnson MedTech has temporarily paused the use of its Varipulse field ablation system in the United States, the company announced.
The move comes after the system used to treat paroxysmal atrial fibrillation was linked to four reported “neurovascular events” in the US external evaluation study, which used a unique platform configuration. “There is no impact to commercial activity and Varipulse cases outside of the US,” the company said.
Johnson & Johnson did not provide details on the four cases, but said it expects to provide more information “within the coming days.”
As part of the US external evaluation, more than 130 cases using the Varipulse platform, across 14 sites and 40 operators, have been completed, the company pointed out. Globally, more than 3000 cases have been completed.
The company said it is “working diligently to complete the investigation according to our medical safety processes and resume the US external evaluation.”
Pause Follows US FDA Approval in Late 2024
The US Food and Drug Administration (FDA) first approved the Varipulse system to treat paroxysmal atrial fibrillation in November 2024.
The fully integrated platform is designed to enable the treatment of atrial fibrillation with a single device that combines pulsed field ablation therapy and advanced 3D navigation and cardiac mapping.
The approval of the Varipulse system was based on positive results from the ADMIRE study, a prospective, multicenter, nonrandomized trial.
Among 277 patients with paroxysmal atrial fibrillation, acute pulmonary vein isolation was successful in 100% of cases, first-pass isolation was achieved in 97.5% of targeted veins, and primary effectiveness success was 74.6%, the study found.
Procedure, fluoroscopy, and pulsed field ablation application times were short, and the primary adverse event rate was low (
The results were published on September 11, 2024, in the journal Circulation.
The Varipulse system is also approved for use in Europe, Canada, and Japan.
Source link : https://www.medscape.com/viewarticle/j-j-halts-varipulse-field-ablation-afib-2025a10000j8?src=rss
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Publish date : 2025-01-10 06:22:54
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