Medtronic Gets FDA Approval to Proceed With Investigational Device Exemption Trial
January 23 2020 - 10:42AM
Dow Jones News
By Michael Dabaie
Medtronic plc (MDT) said it received approval from the U.S. Food
and Drug Administration to proceed with an investigational device
exemption trial of the PulseSelect Pulsed Field Ablation
System.
PulseSelect is a new technology that uses pulsed electric fields
to treat atrial fibrillation. First procedures in the trial were
performed in December 2019, Medtronic said.
In September 2018, Medtronic was granted Breakthrough Device
designation from the FDA for the PFA technology for the treatment
of drug refractory recurrent symptomatic atrial fibrillation.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
January 23, 2020 10:27 ET (15:27 GMT)
Copyright (c) 2020 Dow Jones & Company, Inc.
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