Sophisticated ventricular assist devices (VADs) are now routinely used for bridge to recovery, or bridge to transplant in heart failure patients. However, the success of the VADs' applications in adults has not been translated into that in pediatric application, due to the delays in the miniaturization process of these devices. To date, the need of VADs for infant and child with congenital or acquired cardiovascular disease has largely been unmet. Hundreds of infants and children die each year in the United States while waiting for a donor heart. The goal of this "Fast Track" SBIR application is to develop long-term implantable miniature VADs for infant and child, built upon the success of the current CircuLite Synergy device. The Synergy device is a unique proprietary and patented miniature VAD. Through a decade of development, it has been refined to be the smallest implantable blood pump, only of the size of an "AA" battery. The device is currently undergoing the CE Mark Trial in Europe and pending USFDA IDE submission. The goal of the Phase I project is to demonstrate the feasibility of using the current CircuLite micro-pump (1.5-3 L/min flow) for child (5-35 kg) by modifying the inlet housing of the device for left ventricular apical insertion, while the Phase II project is to demonstrate the feasibility of further modifying the micro-pump (redesigning the impeller or reducing the pump size) to achieve a reduced flow of 0.3-1.5 L/min for use in an infant (<5 kg). The milestone of the Phase I project will be the delivery of a child VAD that has undergone short-term animal studies. In Phase II, we will further test the child VAD in long-term animal studies and freeze its design for future preclinical GLP studies. Meanwhile, we will develop the infant VAD and complete its short-term animal studies.
Public Health Relevance: To date, the need of long-term circulatory support for infant and child with congenital and acquired cardiovascular disease has largely been unmet. The goal of the proposed project is to develop two innovative circulatory support systems for children and infants based upon the unique proprietary and patented CircuLite Synergy Pocket Circulatory Assist Device. The success of these two devices will potentially benefit thousands of infants and children with congenital and acquired cardiovascular disease who otherwise would die each year in the United States while waiting for a donor heart.
Public Health Relevance Statement: Narrative To date, the need of long-term circulatory support for infant and child with congenital and acquired cardiovascular disease has largely been unmet. The goal of the proposed project is to develop two innovative circulatory support systems for children and infants based upon the unique proprietary and patented CircuLite Synergy Pocket Circulatory Assist Device. The success of these two devices will potentially benefit thousands of infants and children with congenital and acquired cardiovascular disease who otherwise would die each year in the United States while waiting for a donor heart.
Project Terms: 0-11 years old; 1,2,3-Propanetriol; 1,2,3-Trihydroxypropane; 21+ years old; Adolescent; Adolescent Youth; Adult; Animal Experiments; Animal Testing; Animals; Apical; Artificial Organs; Assisted Circulation; Award; Baltimore; Belgium; Berlin; Biocompatible; Blood; Blood Circulation; Blood flow; Bloodstream; Body Surface Area; Body Weight; Cardiac; Cardiogenic Shock; Cardiovascular; Cardiovascular Body System; Cardiovascular Diseases; Cardiovascular system; Cardiovascular system (all sites); Child; Child Youth; Childhood; Children (0-21); Chronic; Circulation; City of Berlin; Clinical; Clinical Trials; Clinical Trials, Phase I; Clinical Trials, Unspecified; Computer Simulation; Computerized Models; Contracting Opportunities; Contracts; Development; Devices; Early-Stage Clinical Trials; Electronics; Emergencies; Emergency Situation; Enrollment; Equipment; Ethene, tetrafluoro-, homopolymer; Europe; European; Evaluation; Extracorporeal Membrane Oxygenation; FDA; FEP; Figs; Figs - dietary; Food and Drug Administration; Food and Drug Administration (U.S.); Freezing; Funding; Future; Germany; Glycerin; Glycerol; Goals; Grafting, Heart; HOSP; Heart; Heart Transplantation; Heart failure; Hospitals; Housing; Human; Human, Adult; Human, Child; Human, General; Hybrids; Hydrogen Oxide; Image; Implant; In Vitro; Infant; Lead; Left; Legal patent; Liquid substance; Magnetism; Man (Taxonomy); Man, Modern; Maryland; Mathematical Model Simulation; Mathematical Models and Simulations; Mechanics; Medical; Methods and Techniques; Methods, Other; Miniaturisations; Miniaturization; Miniaturizations; Modeling; Models, Computer; Motor; National Heart, Lung, and Blood Institute; Organ System, Cardiovascular; Outcome Study; Ovis; PTFE; Pace Stimulators; Pacemakers; Patents; Patients; Pb element; Performance; Phase; Phase 1 Clinical Trials; Phase I Clinical Trials; Phase I Study; Polytef; Polytetrafluoroethylene; Power Sources; Power Supplies; Preparedness; Procedures; Process; Programs (PT); Programs [Publication Type]; Protocol; Protocols documentation; Pump; QOL; Quality of life; Readiness; Recovery; Reticuloendothelial System, Blood; Risk; SBIR; SBIRS (R43/44); Safety; Series; Sheep; Simulation, Computer based; Small Business Innovation Research; Small Business Innovation Research Grant; Social Support System; Stimulators, Electrical, Pace; Support System; System; System, LOINC Axis 4; TFE; Techniques; Technology; Testing; Thrombosis; Time; Translating; Translatings; Transplantation; Transplantation, Cardiac; USFDA; United States; United States Food and Drug Administration; Universities; Validation; Vascular, Heart; Velocimetries; Ventricular; Water; adult human (21+); base; biocompatibility; biomaterial compatibility; biomedical implant; blood pump; cardiac failure; cardiac graft; cardiovascular disorder; children; circulatory assist; circulatory system; clinical investigation; commercialization; computational modeling; computational models; computational simulation; computer based models; computerized modeling; computerized simulation; data acquisition; design; designing; digital; effective therapy; enroll; ergonomics; experience; experiment; experimental research; experimental study; fluid; heart transplant; heavy metal Pb; heavy metal lead; hemodynamics; imaging; implant device; implantable device; implantation; improved; in silico; in vivo; indwelling device; innovate; innovation; innovative; juvenile; juvenile human; language translation; liquid; magnetic; manufacturing process; meetings; model design; multidisciplinary; novel; particle; pediatric; phase 1 study; phase 1 trial; phase I trial; pilot trial; pre-clinical; preclinical; programs; protocol, phase I; prototype; public health relevance; research study; success; tool; transplant; usability; ventricular assist device; virtual simulation; youngster
