Medtronic plc has announced the enrollment of the first patient in the PEripheral Onyx™ Liquid Embolic (PELE) clinical trial. The study aims to evaluate the safety and effectiveness of the Onyx™ Liquid Embolic System (LES) for embolization of arterial hemorrhage in the peripheral vasculature, defined as areas outside the brain and heart. This pivotal, prospective, multi-center, non-randomized, single arm study will involve up to 119 patients across 25 sites in the United States. The trial is designed to gather evidence necessary for U.S. physicians to use Onyx LES for this indication, as it is currently available in many markets outside the U.S. The primary safety and efficacy endpoints will be assessed within 30 days following treatment. Results from the study are yet to be presented.
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