SBIR-STTR Award

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.

Public Health Relevance:
This project seeks to develop a miniature implantable blood pump to assist the right side of the heart in pushing blood through the lungs and to the left side of the heart to be circulated through the body. Right-sided heart failure occurs in one fifth of patients receiving left ventricular assist devices to treat heart failure and in other disease such as pulmonary hypertension, where an increased workload on the right heart leads to compromised function, then failure. Currently, there are no devices suitable for long-term use to treat right heart failure.

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.

Public Health Relevance Statement:
This project seeks to develop a miniature implantable blood pump to assist the right side of the heart in pushing blood through the lungs and to the left side of the heart to be circulated through the body. Right-sided heart failure occurs in one fifth of patients receiving left ventricular assist devices to treat heart failure and in other disease such as pulmonary hypertension, where an increased workload on the right heart leads to compromised function, then failure. Currently, there are no devices suitable for long-term use to treat right heart failure.

Project Terms:
Acute; Admission activity; American; Animal Experiments; Animals; base; Biocompatible; Biological Assay; biomaterial compatibility; Blood; blood pump; Chronic; Clinical; Clinical Trials; Colon Carcinoma; commercialization; Complex; Congestive Heart Failure; data acquisition; Data Set; design; Development; Devices; disabling disease; Disease; Early treatment; Economic Burden; Equipment; Europe; experience; Failure (biologic function); falls; Feasibility Studies; Freezing; Funding; Generations; Healthcare; Heart; Heart failure; Heart Transplantation; hemodynamics; Hemorrhage; Home environment; Hospitals; Hour; Implant; Implantable Pump; implantation; improved; In Vitro; in vivo; Infection; innovation; Intravenous; Label; Lead; Left; Length of Stay; Life; Liquid substance; Lung; malignant breast neoplasm; Malignant neoplasm of prostate; Measures; Mechanics; Medical; Medicare; meetings; Modeling; Monitor; Mortality Vital Statistics; novel; novel strategies; Operative Surgical Procedures; Pacemakers; Patients; Performance; Peripheral; Pharmaceutical Preparations; Phase; Phase III Clinical Trials; Power Sources; Preparation; Preventive Intervention; programs; prototype; Pulmonary Hypertension; Pump; Recording of previous events; Regimen; research and development; Resort; Right ventricular structure; Right-On; Risk; Safety; Side; Small Business Innovation Research Grant; Source; Staging; Stents; survivorship; System; Technology; Testing; Thromboembolism; tool; Transplantation; Trauma; Validation; Ventricular; ventricular assist device; Waiting Lists; Workload