Magscrew TAH Testing thru Pre-Clinical Readiness

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DESCRIPTION (Verbatim from Applicant's Abstract):The fundamental goal of the proposed program is to bring to the point of clinical readiness a new electrically powered, totally implantable TAH, based on the Magscrew actuator and the biolized blood pump. The specific aims to meet this goal are: (1) To design and develop an advanced technology, fail safe, electronic control unit (ECU), which will maintain the patient's life after an electrical failure, until maintenance is performed. The ECU also contains hardware and patient monitoring capability, and a telemetry function. (2) To build and test refined versions of the remaining system components, based on current state of the art technology. (3) To integrate the components into a functional, complete system. (4) To perform in-vivo performance tests, exercising system capabilities. (5) To perform in-vivo durability tests. (6) To perform bench endurance tests. (7) To complete this work in compliance with FDA Design Control Regulations. As a consequence of this design and testing effort, surgeons will have another, superior choice among relatively limited TAH alternatives. The "biolized" pump of the Magscrew TAH has pericardial valves combined with biological, protein blood contacting surfaces, and a long track record of extremely rare thrombo-embolic episodes in calves, despite the absence of anti-coagulation. In addition, the Magscrew actuator is the conceptually simplest and most rugged of those available for TAH's, with very few contacting or rubbing surfaces. Mechanical failures have very few possible sources, which clearly increases both reliability and long-term durability. The "fail safe" controller will address the residual pinched wire, corroded solder joint, software hang-up and similar problems that are unavoidable, even with the best fundamental design, and rigorous quality control, in sophisticated, densely packed electronics that are implanted in a hostile environment, and that have caused failures of other, older systems. While the clinical need for TAH's is consistently estimated to be much smaller than for VAD's, it is of a size both nationally and internationally to be of commercial significance. In the United States, it may exceed $1B per year in potential sales. The TAH market will support several suppliers, if not as many as now pursuing the VAD market. To those patients who will need a TAH, the potentially very limited supply of alternatives is of literally life and death significance.