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CE Marking Submission Of SynCardia’s Companion Discharge Driver Is Under Review

The British Standards Institution (BSI) is working on an Onsite FastTrack Review of the European CE marking application for the Companion Driver System that powers the CardioWest temporary Total Artificial Heart (TAH-t) in the operating room, the ICU and for discharge. The BSI may complete the CE Marking review process in 45 working days. The CardioWest artificial heart, the “Big Blue” hospital driver and the European portable driver already received CE marking 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.” European patients with CardioWest artificial heart can wait up to two years for a matching human heart. The supply of donor hearts worldwide remains flat due to growing demand. In 2007, CardioWest implants accounted for 20 patient years of life on the artificial heart. In 2008, that number grew to 30, a 50% increase in patient years with only a 4% increase in the number of implants. Stable CardioWest patients can enjoy a near-normal quality of life at home due to Discharge drivers while they wait for a matching donor heart. It allows patients to shop, travel, visit family and friends and live life like people with human hearts.