Press Release:

TUCSON, Ariz. – Sept. 1, 2004 – SynCardia Systems, Inc., a privately held developer of biomechanical cardiac replacement and assist devices, today announced the appointment of Carole E. Marcot to the position of Vice President of Quality and Regulatory Affairs. Ms. Marcot brings more than two decades of experience in establishing and managing quality programs in compliance with state, federal and international laws for medical device companies and preparing marketing applications for submission to the federal Food and Drug Administration (FDA).

Prior to joining SynCardia, Ms. Marcot most recently served as Vice President, Regulatory Affairs and Quality Systems at Ventana Medical Systems, managing the Regulatory Affairs Department and establishing the Quality Engineering Department. Previously, Ms. Marcot served as Vice President, Worldwide Regulatory Affairs and Quality at Impulse Dynamics Inc., and Vice President, Regulatory and Clinical Affairs at CardioGenesis Corporation. She also worked at Baxter Healthcare Corporation, serving as Vice President, Quality, for Baxter Novacor, where she established compliance programs for left ventricular assist devices (LVADs). Ms. Marcot earned a B.A. from the College of St. Elizabeth, an M.B.A. from University of California, Irvine, and a J.D. from Western State University College of Law. She is a member of the California Bar.

“Carole’s appointment comes at an exciting time for SynCardia, as we expect near-term approval of the CardioWest™ temporary Total Artificial Heart and we continue to grow our investigator and user base in Europe. Carole’s leadership and contributions in helping us navigate the regulatory process will be instrumental as we seek clearance for future products and expand regulatory approval both in the U.S. and abroad,” said Dr. Marvin J. Slepian, CEO and president, SynCardia Systems.

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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