Press Release:

Dr. Marvin Slepian

TUCSON, Ariz. – March 2, 2010 – On March 2, Dr. Marvin Slepian, world-renowned interventional cardiologist and co-founder and chairman of SynCardia Systems, Inc., manufacturer of the SynCardia temporary CardioWest™ Total Artificial Heart, was the keynote speaker at the Medical Devices Summit 2010 held in Boston. The conference highlighted key strategies for regulatory compliance, including the latest tips for streamlining the medical device approval process.

“In 2004, SynCardia’s Total Artificial Heart became the first and only Total Artificial Heart in the world to receive Pre-Market Approval from the FDA,” said Dr. Slepian. “In 2008, SynCardia also successfully petitioned the Centers for Medicare & Medicaid Services to reverse its 1986 national non-coverage policy for artificial hearts and approve reimbursement through the highest paying Diagnostic Related Group codes.”

The SynCardia temporary CardioWest™ Total Artificial Heart

In addition to discussing the development and clinical use of the Total Artificial Heart, Dr. Slepian also addressed the future of SynCardia technologies currently under development, including its new family of pneumatic drivers for powering the Total Artificial Heart and the smaller 50cc Total Artificial Heart designed for women and patients of smaller stature.

Dr. Slepian is Professor of Medicine (Cardiology), Director of Interventional Cardiology and Director of the Tissue Engineering Lab at the University of Arizona. He has founded numerous medical device companies and has served as acting CEO and Board Member of several medical device startups. Additionally, Dr. Slepian has conducted extensive research, development and pre-clinical investigation of novel cardiovascular therapeutic methods and devices.

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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