Development of a Miniature Right Heart Support Device

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DESCRIPTION (provided by applicant): Congestive heart failure (CHF) is one of the most serious medical challenges of our day. With 5 million Americans compromised by the ravages of this disabling disease, CHF is the leading cause of Medicare hospital admissions. The economic burden exceeds $40 billion annually. A comprehensive approach to this ominous healthcare threat includes prevention and early intervention, an ever-increasingly complex medication regimen, surgical treatments, and devices such as stents and pacemakers. Despite these available therapies, heart failure for many remains progressive. Current approaches to replacement include heart transplantation and blood pumps to provide mechanical circulatory support. While clearly important, transplantation falls short of meeting the CHF need - only 6 donor hearts today for the 3,000 on the waiting list - only 2,200 a year for the 50,000 who need heart replacement but will never get a donor heart. The current generation of heart pumps, known as Left Ventricular Assist Devices (LVADs) have demonstrated the remarkable capacity of technology to extend life with quality. Survivorships are approaching that of heart transplantation and patients are living functional lives at home. However, there is still much need for improvement to reduce complications including: bleeding (10-30% of recipients), infection (30-50%), and thromboembolism (6-20%). Right ventricular failure occurs in 20-44% of LVAD recipients following the pump implant, prolonging ICU and hospital length of stay, requiring continued indwelling lines for intravenous medications (an infection risk), and significantly increasing the risk of mortality, yet there are no suitable chronic right ventricular assist devices (RVAD). Thus, we propose to develop the world's smallest implantable blood pump, the REVOLUTION, to serve as a surgically implantable adjunct to existing LVADs to provide chronic treatment of right ventricular failure. The circulatory support device proposed for development in this SBIR proposal is based on a novel miniature hydrodynamic bearing concept. Therefore, we propose a Fast Track, combined Phase I/II SBIR program with the objectives: (1) to demonstrate the feasibility and efficacy of the pump as an RVAD in vitro and short term animal experiments during the Phase I effort; (2) to conduct chronic animal implants to evaluate the long-term function, biocompatibility, and durability of the system during the Phase II. By the end of the program, we will reach a "design freeze" clinical blood pump system in preparation for clinical trial and Phase III funding.