Press Release:

TUCSON, Ariz. – Feb. 9, 2010 – On Jan. 22, Danny Bluestein, PhD, Professor of Bioengineering at the State University of New York (SUNY) Stony Brook, in collaboration with Marvin J. Slepian, M.D., Professor of Medicine (Cardiology) at the University of Arizona, submitted a Phase II Quantum Grant proposal to the National Institute of Biomedical Imaging and Bioengineering (NIBIB).

“During Phase I of this project, we developed and tested the Device Thrombogenicity Emulator (DTE),” said Dr. Bluestein. “The DTE measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device as extracted from advanced numerical simulations. Conceptually, it is analogous to a wind tunnel used for aeronautic and automotive testing.

“The ultimate goal is to eliminate the need for anticoagulation. During Phase II, we plan to use the DTE to identify ‘hot spot’ trajectories in the flow fields of cardiovascular devices where clots can form. The DTE methodology enables us to tweak the geometry of the device in order to achieve design optimization aimed at minimizing and eliminating these hot spots.”

If the proposal is awarded the grant, Dr. Bluestein plans to use the DTE to test and optimize the designs of prosthetic heart valves, left ventricular assist devices (LVADs), biventricular assist devices (BiVADs) and the SynCardia temporary CardioWest™ Total Artificial Heart. Dr. Bluestein closely collaborates with SynCardia Systems, Inc., and with other device manufacturers who are partners in the proposal.

“Ultimately, we envision that our methodology has the potential for advancing testing for cardiovascular devices that may be of use to the industry and the FDA,” said Dr. Slepian.

According to the NIBIB website, the Quantum Grants Program was established to make a profound (quantum) improvement in health care. This program challenged the research community to propose projects that have a highly focused, collaborative, and interdisciplinary approach targeted to solve a major medical problem or to resolve a highly prevalent technology-based medical challenge.

The Device Thrombogenicity Emulator measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device as extracted from advanced numerical simulations.

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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