FDA Grants ‘Breakthrough Device Designation’ to Fully Implantable Heart Pump

Medtronic plc, a global specialist in medical technology, has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for the Medtronic Fully Implantable Left Ventricular Assist Device (LVAD) for patients with advanced heart failure, currently in development.
 
Currently, LVAD systems include an implanted heart pump to increase the amount of blood that circulates through the body. The pump is connected to a driveline cable that extends outside the body to a controller, which is connected to power sources (AC or DC adapter, batteries). The future system is designed to be fully implanted inside the body.
 
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Medtronic with priority review and interactive communication regarding device development and clinical trial protocols, through to commercialization decisions.
 
The Medtronic Fully Implantable LVAD is in early-stage research and development, and is not available for sale anywhere in the world.