Dr. Marvin Slepian Publishes Article in Journal of Biomechanics on Downsizing the SynCardia temporary Total Artificial Heart
SynCardia Co-Founder Inducted into College of Fellows for the American Institute for Medical and Biological Engineering
TUCSON, Ariz. – March 14, 2013 – SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart (TAH), announced today that Marvin J. Slepian, MD, the company's co-founder, chief scientific officer and chairman of the Science Advisory Board, has published a 10-page article in the Journal of Biomechanics (JBM) titled, "The SynCardia total artificial heart: in vivo, in vitro, and computational modeling studies."
“Looking to the future a major unmet need remains in providing total heart support for children and small adults,” wrote Dr. Slepian, Professor of Medicine (Cardiology and Biomedical Engineering) at the University of Arizona. “As such, the present TAH design must be scaled to fit the smaller patient, while providing equivalent, if not superior flow characteristics, shear profiles and overall device thrombogenicity. To aid in the development of a new pediatric TAH, an engineering methodology known as Device Thrombogenicity Emulation (DTE) that we have recently developed and described is being employed.”
DTE measures the potential for blood clotting in cardiovascular devices by mimicking the conditions in the device based on sophisticated numerical simulations. It can then be used to tweak the geometry of the device to optimize the design and minimize or eliminate "hot spot" trajectories where clots can form.
“With increasing adoption of this technology [the Total Artificial Heart] and expanding patient populations that stand to benefit from its use as destination therapy, it may be even further improved through thromboresistance optimization,” concluded Dr. Slepian. “Additionally, engineering demands exist for evolutionary designs that are smaller and utilize new mechanical valves. The DTE methodology is an effective means of rapidly extending and improving the TAH design to create smaller, durable TAH systems with minimized overall thrombogenicity.”
In January, the U.S. Food and Drug Administration (FDA) approved two Humanitarian Use Device (HUD) designations for SynCardia’s smaller 50cc Total Artificial Heart to be used for destination therapy and pediatric bridge to transplant. The next step is for SynCardia to submit a Humanitarian Device Exemption application for each indication to the FDA for approval. Once approved, the HDEs will allow up to 4,000 U.S. patients annually to receive the 50cc Total Artificial Heart as destination therapy, and an additional 4,000 pediatric patients to receive the device as a bridge to transplant.
Dr. Slepian is the Director of Interventional Cardiology and Director of the Tissue Engineering Lab at the University of Arizona. On Feb. 18, he was inducted into the American Institute for Medical and Biological Engineering (AIMBE) College of Fellows, which is comprised of the top two percent of medical and biological engineers in the U.S. Dr. Slepian was nominated by peers and elected by the full membership into the Class of 2013 for “seminal contributions to implantable device design and development, and for entrepreneurial leadership in founding and advancing innovative medical firms.”
About SynCardia Systems, LLC
SynCardia Systems, LLC in Tucson, Ariz., is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. For people suffering from end-stage heart failure affecting both sides of the heart (biventricular failure), the SynCardia temporary Total Artificial Heart is used as a bridge to transplant, helping them survive until a matching donor heart becomes available. SynCardia also manufactures the Freedom® portable driver, which powers the temporary Total Artificial Heart and allows clinically stable patients to be discharged from the hospital to enjoy life at home while they wait for a heart transplant.
Janelle Drumwright, email@example.com, (520) 547-7463