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.
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