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SynCardia Announces Review Of Companion Discharge Driver In BSI FastTrack

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. “The Onsite FastTrack Review is not for the faint of heart. It is designed for customers who have their ducks in a row and are ready to go to market in Europe,” said Dr. Andre Routh, the BSI Senior Product Expert working with SynCardia. “We are working onsite with SynCardia to advance effectively toward European regulatory approval of the Companion Driver System.” “SynCardia is taking advantage of a valuable opportunity by participating in the BSI FastTrack Program,” said Rodger Ford, CEO and president of SynCardia Systems, Inc., manufacturer of the CardioWest artificial heart. “Once we achieve regulatory approval in Europe and the US, we are projecting a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the following 24 months.”