FDA Breakthrough Device Designation for fully implantable left ventricular assist system

Robert Kormos The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott for its in-development fully implantable left ventricular assist system (FILVAS). The FDA Breakthrough Device Designation programme will allow, according to Robert L Kormos (medical director for mechanical circulatory support at Abbott), the company to “fast track” [...]