By Colin Kellaher
Abbott (ABT) on Tuesday said it received breakthrough-device designation from the U.S. Food and Drug Administration for its fully implantable heart-pump system.
The Abbott Park, Ill., maker of healthcare products said its Fully Implantable Left Ventricular Assist System, which is currently in development, would mean more freedom and a greater quality of life for patients because there are no external components.
Abbott said current left-ventricular-assist devices are implanted into the body and then powered using an external battery pack or charging port.
The FDA's breakthrough-devices program aims to expedite the development and review of technology that offers significant advantages over existing approved products.
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