www.fdanews.com/articles/75002-syncardia-announces-initial-implantation-of-the-cardiowest-temporary-total-artificial-heart-at-the-cleveland-clinic
SYNCARDIA ANNOUNCES INITIAL IMPLANTATION OF THE CARDIOWEST TEMPORARY TOTAL ARTIFICIAL HEART AT THE CLEVELAND CLINIC
August 3, 2005
SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and mechanical circulatory support devices, announced today implantation of its CardioWest(TM) Temporary Total Artificial Heart (TAH-t) in a patient at The Cleveland Clinic. The Cleveland Clinic is the first "new" center, beyond the institutions that previously participated in the recently reported pivotal U.S. multi-center trial, to adopt this technology. The TAH-t received FDA approval allowing commercial distribution in late 2004.