SBIR-STTR Award

Heart failure and congenital heart defects threaten the lives of several thousand children each year. The only FDA-approved long term pediatric heart support device is the Berlin Heart Excor, which is based on 30+ year old technology and is fraught with complications including blood clots forming in the device requiring frequent device replacement. The recipients of this technology are at high risk for strokes, bleeding, and infection and the pumps are driven by a large 220 lb console, which limits patient mobility and prevents hospital discharge. In spite of these severe limitations, 90% of Excor recipients survive to transplant, although the median duration of support is only 35 days. A safer device would dramatically reduce the complications of support, permit discharge to home, and allow doctors to deploy the technology earlier, before a child reaches the brink of death. VADovations is developing a miniature implantable pump platform, the Revolution, in which minor modifications of 2 components can be implemented to adjust the pump performance to support the right or left side of the heart. The devices are 8 mm in diameter and 50 mm in length, about the size of a 'AAA' battery, compared to the market leading Heartmate II, which is 47 mm in maximum diameter and 95 mm in length, the size of a 'D' cell battery. Our adult Revolution RVAD can safely generate the lower blood rates needed for a pediatric left heart assist device and has demonstrated exceptionally low blood trauma in bench-top studies and during implants in sheep for durations up to one month with no long-term blood thinners. Building upon these promising results, we propose a Fast Track, combined Phase I/II SBIR to re-purpose the Revolution RVAD as a pediatric left heart assist device, the Revolution MINI, for children ages 1 and up. Then we will revise the design to create the Revolution NEO for neonates and infants, aged 0-1, who represent the largest clinical need for pediatric heart support. During Phase I, we will demonstrate the feasibility and efficacy of the MINI for pediatric blood flow rates and pressures during in vitro and short term animal experiments. In Phase II, we will conduct chronic animal implants to evaluate the long-term function, biocompatibility, and durability of the pumps and perform verification and validation studies of the Revolution MINI system to prepare for a US clinical trial. Throughout the program, we will focus considerable efforts on anatomic fit modeling and studies to devise approaches so that these devices can be implanted in the smaller bodies of children, to avoid pumps protruding from the body, as occurs with the paracorporeal Excor. Superior hemocompatibility, smaller size, and the ability to leverage adult system components, combine to produce pediatric heart assist devices that will offer fewer complications, permit patient discharge to home, and be economically viable to revolutionize the treatment of pediatric heart failure.

Public Health Relevance Statement:


Public Health Relevance:
Congenital heart defects and acquired heart disease afflict thousands of children each year, yet there are very limited options for physicians to help children reaching end stage heart failure, none of which currently allow the child to be discharged to home. The proposal will adapt a small blood pump primarily being developed for adults to support infants and children with severe heart failure.

Project Terms:
Acute; Adolescent; Adult; Age; aged; Anatomic Models; Anatomy; Animal Experiments; Animals; Anticoagulants; Anticoagulation; base; Berlin; Biological Assay; biomaterial compatibility; Blood; Blood coagulation; Blood flow; blood pump; Caliber; Cannulas; Cardiac; Cessation of life; Child; Childhood; Chronic; Clinical; Clinical Trials; Clinical Trials Design; commercialization; Complication; Congenital Heart Defects; D Cells; design; Development; Devices; Documentation; Extracorporeal Membrane Oxygenation; FDA approved; Funding; Heart; Heart Diseases; Heart failure; Heart Transplantation; Heart-Assist Devices; hemodynamics; Hemolysis; Hemorrhage; high risk; Home environment; Hospitals; Hour; Implant; Implantable Pump; improved; In Vitro; in vivo; Infant; Infection; Left; Length; Liquid substance; Marketing; Measures; meetings; Minor; Modeling; Modification; neonate; Operative Surgical Procedures; Patient Discharge; Patients; Performance; Phase; Physicians; Preparation; pressure; prevent; programs; public health relevance; Pump; Readiness; Safety; sample fixation; Sheep; Side; Small Business Innovation Research Grant; Staging; stroke; Study models; Survival Rate; System; Technology; Testing; Time; Transplantation; Trauma; Ursidae Family; validation studies; ventricular assist device; verification and validation

Heart failure and congenital heart defects threaten the lives of several thousand children each year. The only FDA-approved long term pediatric heart support device is the Berlin Heart Excor, which is based on 30+ year old technology and is fraught with complications including blood clots forming in the device requiring frequent device replacement. The recipients of this technology are at high risk for strokes, bleeding, and infection and the pumps are driven by a large 220 lb. console, which limits patient mobility and prevents hospital discharge. In spite of these severe limitations, 90% of Excor recipients survive to transplant, although the median duration of support is only 35 days. A safer device would dramatically reduce the complications of support, permit discharge to home, and allow doctors to deploy the technology earlier, before a child reaches the brink of death. VADovations is developing a miniature implantable pump platform, the Revolution, in which minor modifications of 2 components can be implemented to adjust the pump performance to support the right or left side of the heart. The devices are 8 mm in diameter and 50 mm in length, about the size of a 'AAA' battery, compared to the market leading Heartmate II, which is 47 mm in maximum diameter and 95 mm in length, the size of a 'D' cell battery. Our adult Revolution RVAD can safely generate the lower blood rates needed for a pediatric left heart assist device and has demonstrated exceptionally low blood trauma in bench-top studies and during implants in sheep for durations up to one month with no long-term blood thinners. Building upon these promising results, we propose a Fast Track, combined Phase I/II SBIR to re-purpose the Revolution RVAD as a pediatric left heart assist device, the Revolution MINI, for children ages 1 and up. Then we will revise the design to create the Revolution NEO for neonates and infants, aged 0-1, who represent the largest clinical need for pediatric heart support. During Phase I, we will demonstrate the feasibility and efficacy of the MINI for pediatric blood flow rates and pressures during in vitro and short term animal experiments. In Phase II, we will conduct chronic animal implants to evaluate the long-term function, biocompatibility, and durability of the pumps and perform verification and validation studies of the Revolution MINI system to prepare for a US clinical trial. Throughout the program, we will focus considerable efforts on anatomic fit modeling and studies to devise approaches so that these devices can be implanted in the smaller bodies of children, to avoid pumps protruding from the body, as occurs with the paracorporeal Excor. Superior hemocompatibility, smaller size, and the ability to leverage adult system components, combine to produce pediatric heart assist devices that will offer fewer complications, permit patient discharge to home, and be economically viable to revolutionize the treatment of pediatric heart failure.

Public Health Relevance Statement:


Public Health Relevance:
Congenital heart defects and acquired heart disease afflict thousands of children each year, yet there are very limited options for physicians to help children reaching end stage heart failure, none of which currently allow the child to be discharged to home. The proposal will adapt a small blood pump primarily being developed for adults to support infants and children with severe heart failure.

NIH Spending Category:
Assistive Technology; Bioengineering; Cardiovascular; Clinical Research; Heart Disease; Pediatric; Rehabilitation

Project Terms:
Acute; Adolescent; Adult; Age; aged; Anatomic Models; Anatomy; Animal Experiments; Animals; Anticoagulants; Anticoagulation; base; Berlin; Biological Assay; biomaterial compatibility; Blood; Blood coagulation; Blood flow; blood pump; Caliber; Cannulas; Cardiac; Cessation of life; Child; Childhood; Chronic; Clinical; Clinical Trials; Clinical Trials Design; commercialization; Complication; Congenital Heart Defects; D Cells; design; Development; Devices; Documentation; Extracorporeal Membrane Oxygenation; FDA approved; Funding; Health; Heart; Heart Diseases; Heart failure; Heart Transplantation; Heart-Assist Devices; hemodynamics; Hemolysis; Hemorrhage; high risk; Home environment; Hospitals; Hour; Implant; Implantable Pump; improved; In Vitro; in vivo; Infant; Infection; Left; Length; Liquid substance; Marketing; Measures; meetings; Minor; Modeling; Modification; neonate; Operative Surgical Procedures; Patient Discharge; Patients; pediatric patients; Performance; Phase; Physicians; Preparation; pressure; prevent; programs; Pump; Readiness; Safety; sample fixation; Sheep; Side; Small Business Innovation Research Grant; Staging; stroke; Study models; Survival Rate; System; Technology; Testing; Time; Transplantation; Trauma; Ursidae Family; validation studies; ventricular assist device; verification and validation