US major Johnson & Johnson (J&J, NYSE: JNJ) MedTech has announced the completion of pilot phase enrollment for the OMNY-AF study, which is assessing the effect of its OMNY-AF platform in symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia. The single-arm, multi-center study aims to enroll up to 410 patients in the pivotal phase across both countries, following the completion of the pilot phase enrollment of 30 patients.
Objectives and Protocols of the OMNY-AF Study
The primary objective of the study is to demonstrate the safety and 12-month effectiveness of the Omnypulse platform for pulmonary vein isolation in the treatment of subjects with symptomatic paroxysmal AFib. The pivotal phase of the study will commence once the U.S. Food & Drug Administration (FDA) completes its review of the acute safety data from the pilot group.
The Omnypulse Platform: Integrating PFA Therapy and Mapping
The Omnypulse platform, which includes the Omnypulse Catheter—a large-tip, 12 mm focal catheter with contact force sensing—and the Trupulse Generator, is designed to facilitate AFib treatment strategies. The platform combines Pulsed Field Ablation (PFA) therapy with mapping via the CARTO 3 System, the world’s leading 3D heart mapping system.- Flcube.com
