Medtronic Gets FDA Breakthrough Device Designation for Heart Device
October 29 2019 - 12:47PM
Dow Jones News
By Chris Wack
Medtronic PLC (MDT) said Tuesday it has received Breakthrough
Device designation from the U.S. Food and Drug Administration for
the Medtronic Fully Implantable Left Ventricular Assist Device, or
LVAD, for patients with advanced heart failure, currently in
development.
The medical technology company said the FDA will provide
Medtronic with priority review and interactive communication
regarding device development and clinical trial protocols, through
to commercialization decisions.
Medtronic's LVAD systems include an implanted heart pump to
increase the amount of blood that circulates through the body.
Medtronic said its fully implantable LVAD is in early-stage
research and development, and isn't available for sale anywhere in
the world.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 29, 2019 12:32 ET (16:32 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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