SynCardia Systems, Inc. Fast Tracks CE Marking Submission for Companion Discharge Driver

TUCSON, Ariz.--(BUSINESS WIRE)--During the week of Jan. 19-23, the British Standards Institution (BSI) is performing an Onsite FastTrack Review of the European CE Marking application for the Companion Driver System. This system is intended to power the CardioWest™ temporary Total Artificial Heart (TAH-t) in the operating room, the ICU and for discharge. Although not guaranteed, the goal of the BSI program is to complete the CE Marking review process in 45 working days. SynCardia currently has the CE Marking for the CardioWest artificial heart, the “Big Blue” hospital driver and the European portable driver through BSI.

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