Johnson & Johnson MedTech Completes Pilot Phase Enrollment for Innovative Catheter
Johnson & Johnson MedTech, a global leader in cardiac arrhythmia treatment, announced the completion of patient enrollment for the pilot phase of the OMNY-AF clinical trial. This study is evaluating the investigational OMNYPULSE™ Platform for treating symptomatic paroxysmal atrial fibrillation (AFib) in the United States and Australia. OMNY-AF is a prospective, single-arm, multi-center trial that has enrolled 30 patients in its pilot phase and aims to include up to 410 additional participants in its pivotal phase. The main goal of the trial is to establish the safety and 12-month effectiveness of the OMNYPULSE™ Platform for pulmonary vein isolation in patients with symptomatic paroxysmal AFib. The pivotal phase will commence following the U.S. Food & Drug Administration (FDA) review of acute safety data from the pilot phase.
Johnson & Johnson MedTech Completes Pilot Phase Enrollment for Innovative Catheter