Press Release:

In February 2009, SynCardia will submit an application to the FDA to conduct an IDE clinical study of the Companion Discharge Driver in the US.

TUCSON, Ariz. – Jan. 22, 2009 – 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.

The Companion Hospital Cart is designed for use in the operating room and ICU.

“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.”

The Companion Discharge Driver is designed to allow stable CardioWest artificial heart patients to recover at home.

“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 U.S., we are projecting a 400% increase in the number of patients benefiting from the CardioWest artificial heart in the following 24 months.” 

In Europe, CardioWest artificial heart patients can wait up to two years for a matching human heart. While demand is growing, the supply of donor hearts worldwide remains flat. 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.

Discharge drivers allow stable CardioWest patients to enjoy a near-normal quality of life at home while they wait for a matching donor heart. Many of these patients can shop, travel, visit family and friends and live life like people with human hearts.

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About the SynCardia temporary Total Artificial Heart
SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, SynCardia's Total Artificial Heart is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. There have been more than 950 implants of the Total Artificial Heart, accounting for more than 230 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves, eliminating the symptoms and source of end-stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at SynCardia Certified Centers and does not require expensive anti-rejection medication, which can cause subsequent complications. It is the only device that provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

SynCardia Ranked #20 Among World's 50 Most Innovative Companies
In March 2011, Fast Company magazine ranked SynCardia #20 in its annual list of the "World's 50 Most Innovative Companies" for "giving mobility to artificial heart recipients." Weighing 13.5 pounds, SynCardia's Freedom® portable driver is the world's first wearable driver designed to power the Total Artificial Heart both inside and outside the hospital. The Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

For additional information, please visit: http://www.syncardia.com
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Media Contact:
Don Isaacs
Vice President of Communications
SynCardia Systems, Inc.
Cell: (520) 955-0660