An electromechanically driven totally implantable total artificial heart (TAH) was developed recently at Baylor College of Medicine. This experimental prototype was proven to be reliable and effective, yet small enough to implant inside the chest cavity of an average human patient. This TAH system was assembled by selecting and combining the best, simplest and most reliable features available from NHLBI's TAH contract programs. Commercially available components with already proven long-term performances were used for this system. Now this experimental prototype TAH is ready to move onto the next stage of development. Fabrication of a preproduction prototype TAH has to move from the laboratory to a commercial firm. We will fabricate four TAHs during Phase I. In vitro characterization of these units will be studied and results compared with those of the unit fabricated at the laboratory at Baylor. Reproducibilities of their performance among these four units will be studied. Long-term in vivo validation and endurance studies will be the main aim of Phase II.Awardee's statement of the potential commercial applications of the research:By 2010, it is estimated that 10,000 to 20,000 patients per year will require a total artificial heart TAH with an estimated cost of $100,000 each, in 1991 dollars. This translates into a potential $1 to $2 billion market.National Heart, Lung and Blood Institute (NHLBI)
