J&J: recruitment to evaluate Omnypulse platform

(CercleFinance.com) - Johnson & Johnson announces that its MedTech division has completed the pilot phase of recruitment for the OMNY-AF clinical trial, investigating the investigational Omnypulse platform for the treatment of symptomatic paroxysmal atrial fibrillation (AF).


The trial has completed the pilot phase of recruitment with 30 patients, and aims to include up to 410 additional patients in the pivotal phase in the USA and Australia. The study will aim to demonstrate the safety and efficacy of the platform for pulmonary vein isolation.

The primary objective is to demonstrate the 12-month safety and efficacy of the Omnypulse platform for pulmonary vein isolation in patients with symptomatic paroxysmal AF.

The pivotal phase will begin once the FDA (Food & Drug Administration) has reviewed the acute safety data from the pilot group.


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