Biosense Webster, part of Johnson & Johnson MedTech, has announced the first cases with its investigational OMNYPULSE™ Catheter as part of the Omny-IRE clinical trial in Belgium. The Omny-IRE clinical trial is a pivotal, prospective, multi-center, non-randomized study that will enroll approximately 135 patients in Europe and Canada to evaluate the safety and effectiveness of the Biosense Webster OMNYPULSE™ Platform, the principal components of which are the OMNYPULSE™ Catheter and the TRUPULSE™ Generator. The study will evaluate the platform for the mapping and treatment of symptomatic paroxysmal atrial fibrillation (AFib) during standard ablation procedures.
Medical Device Supply Chain Council