BiVACOR Rotary Total Artificial Heart

SUMMARY ABSTRACT Heart FailureHFis a devastating disease affecting more thanmillion patients worldwidewithmillion of these American at an incidence ofnew cases each yearWhilst heart transplants provide the best treatment option for many of these patientsless thanheart transplants take place globally each yearFurthermorecurrent growth rates predict aincrease in the incidence of HF byat an expected cost of USD$B per annumThe US National Institute of HealthNIHestimated thatpatients could immediately benefit from mechanical circulatory supportMCSPatients with severe heart failure have a poor outlook without interventionDrug therapy is not an effective optionand the limited availability of donor hearts suggests the only viable alternative at this point in time is MCSVentricular assist devicesVADsand Total Artificial HeartsTAHsare mechanical pumps that are surgically implanted alongside or in replacement of the heart of patients with severe HFto restore the adequate blood flowTechnological advances in the field have addressed many issues associated with isolated left ventricular HF resulting in the commercialization of a number of left ventricular assist devicesLVADsHoweverup toof HF patients have biventricular HFor it develops after LVAD implantationThis necessitates the removal of the heart and implantation of a TAHor the implantation of a second VAD alongside the right heart to provide biventricular assistanceBiVADHoweverthere are no long term biventricular devices that adequately meet the needs of this population due to concerns regarding durability and adverse eventsThe BiVACOR device is poised to take advantage of this market gapThe BiVACOR TAH utilizes the same approach as the modern successful LVADs which are based on rotary blood pumpRBPtechnology with magnetically levitated rotorsand applies it to provide simultaneousreliable and biocompatible support for both the systemic and pulmonary circulationsThe device has progressed though concept and feasibility phase I via private funding sourcesand is now entering the development phase IIThereforethis SBIR proposal is targeting a direct to phase II applicationwith the following specific aimsImplement and refine speed control algorithms to restore pulsatility and outflow adaptationRefine the design of implantable components while achieving an optimized human anatomical fitConstruct hermetically sealed devices under design controlsandVerification of processes and validation of device function in vitro and chronic in vivoAttainment of these milestones would lead to a design freeze whilst demonstrating the clinical utility of this productraising the profile of the technologyand thus encouraging the additional investment needed to enter into Phase III commercializationThe impact of a long term practical mechanical replacement to the failing human heart for menwomen and children would be tremendousPatients would no longer need to wait for a heart transplant to return to a vastly improved quality of lifeLeveraging the successful durability and small size of similar VAD technologies into the BiVACOR TAH provides a clear pathway to achieve the goal of a practical replacement of the failing human heart