Labtype to Preclinical Prototype VAD

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DESCRIPTION (provided by applicant): Perfusion Solutions, Inc. (PSI) has licensed the "MiniMixedFlow" (M2F) pump technology from the Cleveland Clinic. This Fast-Track SBIR application is intended to overcome the remaining obstacles to major commercial investment leading to qualification for clinical use. The patent applied for configuration employs passive magnetic bearings, a miniature motor, and a mixed flow impeller to build a durable pump of high output relative to its size. The configuration is extremely flexible and adaptable. Hardware prototypes addressing multiple clinical niches have been built. Excellent bench results and very preliminary in vivo data have been obtained with "labtype" hardware built with shortcuts to enable expeditious evaluation of the most fundamental design questions. Hardware to date has shown good hydraulic performance, low hemolysis, very long life and preliminary in vivo results, compromised by construction shortcuts necessary in the lab program. The key remaining feasibility issue is freedom from deposition/embolic events under chronic implant conditions. PSI proposes to build a preclinical prototype pump using refined construction and finishing techniques. During phase I of this fast-track proposal, we will demonstrate: 1) that the preclinica hardware maintains the basic performance and hemolysis results of the preliminary hardware; 2) that the durability shows no change relative to the labtype in the early stages of a new endurance test series; and, 3) good biocompatibility is shown in two 30-day in vivo studies. The success criteria for (1) and (2) are comparisons to the matching data of the lab- type pumps, while (3) will be judged by an absence of deposition in the pump or of thromboembolic complications downstream attributable to the pump. With acceptance from the NIH program officer of phase I results, phase II will build more pump hardware and a preclinical prototype console, launch an extended in vivo demonstration study and continue the bench endurance testing. With this data the last barrier to overcome in order to raise significant phase III commercial investment will have been breached. PUBLIC HEALTH RELEVANCE: Heart disease is a major source of mortality, loss of quality of life, and high medical costs for treatment. Blood pumps have shown a potential to not only save lives, but to rehabilitate patients to a much higher level of function. However, present technology still has a significant number of limitations which cause death and disability as a result of the pump implant; the proposed project addresses many of these limitations.