SynCardia 50cc Total Artificial Heart Wins FDA HUD Designations for Children and Small Adults
SynCardia, maker of the Total Artificial Heart, has announced the development of and two FDA Humanitarian Use Device (HUD) designations for the smaller 50cc version of the mechanical heart. At 70cc the original device is considerably larger, and downsizing the componentry required substantial creativity by the engineering team.
The HUD designations by the FDA are for the 50cc Total Artificial Heart to be used as a destination therapy for people with a failing heart and as a bridge-to-transplant for those that have a body surface area between 1.2m2 and 1.79m2. Dr. Marvin Slepian, co-founder and chief scientific officer at SynCardia, has published an article in Journal of Biomechanics describing the background and development of the smaller mechanical heart.
“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.”
