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Medtronic Receives FDA Approval For Trial Evaluating New Energy Source With Pulsed Electric Fields To Treat Atrial Fibrillation

Medtronic plc (NYSE:MDT) today announced that it received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and

Benzinga · 01/23/2020 15:00

Medtronic plc (NYSE:MDT) today announced that it received approval from the U.S. Food and Drug Administration (FDA) to proceed with an investigational device exemption (IDE) trial to evaluate the safety and effectiveness of the PulseSelect™ Pulsed Field Ablation (PFA) System, a new technology that uses pulsed electric fields to treat atrial fibrillation. First procedures in the trial were performed in December 2019 by Bradley Wilsmore, M.D., at John Hunter Hospital, New Lambton Heights, NSW, Australia and in January by Atul Verma, M.D., the principal investigator (PI) for the study, at Southlake Regional Health Centre in Newmarket, Canada.