The overall objective of this proposed program is the commercialization of the Pediatric Impella system, a minimally invasive ventricular assist device (VAD) for treatment of acute heart failure in pediatric patients. The device will be a less traumatic alternative to extracorporeal membrane oxygenation (ECMO), the current standard of care for these patients. The target patient population is in the age and weight range of 3 mos - 3 yrs and 5-15 kg. The Pediatric Impella system will be designed to unload the left ventricle and promote cardiac recovery, providing blood flow in the range of 0.5-2 lpm for up to 2 wks of support. Reviewers pointed out in discussion that the device is not as minimally invasive as claimed and will require more anticoagulation than is suggested in the application. Since there are only a few devices in the field for this problem, this proposal addresses a great unmet clinical need and has high significance.
Public Health Relevance: It is estimated that approximately 9,000 infants born with congenital heart defects each year in the U.S. require some form of invasive intervention during the first years of life. Many of these children require mechanical circulatory support as a bridge to recovery or to transplant. Shorter duration of support (for days to at most a few weeks) for acute, generally recoverable heart failure is mostly provided by extracorporeal membrane oxygenation (ECMO). ECMO is highly invasive and is associated with a host of complications including blood clots, bleeding, ongoing heart failure, and strokes. Therefore, a strong unmet clinical need exists for a minimally invasive ventricular assist device (VAD) that can supplant ECMO for treatment of acute heart failure in pediatric patients.
Thesaurus Terms: 0-11 Years Old; 0-6 Weeks Old; 21+ Years Old; Absence Of Interventricular Septum; Acute; Address; Adult; Age; Algorithms; Anatomic; Anatomical Sciences; Anatomy; Animals; Anticoagulation; Aorta, Ascending; Aortic Valve; Aortic Valve Structure; Apoplexy; Area; Ascending Aorta Structure; Aspiration, Mechanical; Autopsy; Birth Defects; Bleeding; Blood; Blood Clot; Blood Clotting; Blood Loss, Postoperative; Blood Coagulation; Blood Flow; Cadaver; Cannulas; Cardiac; Cardiac Abnormalities; Cardiac Catheterization Procedures; Cardiac Defects, Congenital; Cardiac Diseases; Cardiac Disorders; Cardiac Malformation; Cardiac Defect; Cardiology; Cardiovascular Disease (Specialty); Carotid Artery, External; Catheterization, Cardiac; Catheters; Cerebral Stroke; Cerebrovascular Apoplexy; Cerebrovascular Stroke; Cerebrovascular Accident; Characteristics; Child; Child Youth; Childhood; Children (0-21); Chronic; Classification; Clinical; Clinical Trials; Clinical Trials, Unspecified; Common Ventricle; Complex; Computer Programs; Computer Simulation; Computer Software; Computerized Models; Congenital Abnormality; Congenital Anatomic Abnormality; Congenital Anatomical Abnormality; Congenital Defects; Congenital Deformity; Congenital Heart Defects; Congenital Malformation; Cor Triloculare Biatriatum; Detection; Development; Device Designs; Device Or Instrument Development; Devices; Diagnosis, Antenatal; Drainage, Suction; Event; External Carotid Artery Structure; Extracorporeal Membrane Oxygenation; Funding; Heart Abnormalities; Heart Catheterization; Heart Catheterization Pocedure; Heart Defects, Congenital; Heart Diseases; Heart Malformation; Heart Failure; Hemolysis; Hemorrhage; Human, Adult; Human, Child; Image; In Vitro; Incidence; Infant; Infant, Newborn; Insertion Of Catheter Into Heart Chamber; Intervention; Intervention Strategies; Intrauterine Diagnosis; Laboratories; Left Ventricles; Left Ventricular Structure; Life; Mr Imaging; Mr Tomography; Mri; Magnetic Resonance Imaging; Magnetic Resonance Imaging Scan; Mathematical Model Simulation; Mathematical Models And Simulations; Measurement; Mechanics; Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance; Methods And Techniques; Methods, Other; Models, Computer; Molecular Genetic Abnormality; Motor; Nmr Imaging; Nmr Tomography; Nature; Neurologic; Neurological; Newborn Infant; Newborns; Normal Range; Normal Values; Nuclear Magnetic Resonance Imaging; Operation; Operative Procedures; Operative Surgical Procedures; Patients; Performance; Peripheral; Phase; Physiologic; Physiological; Post-Operative Hemorrhage; Postoperative Bleeding; Postoperative Hemorrhage; Prenatal Diagnosis; Preparation; Programs (Pt); Programs [publication Type]; Pump; Recovery; Reticuloendothelial System, Blood; Risk; Sched; Safety; Schedule; Scheme; Science Of Anatomy; Simulation, Computer Based; Software; Speed; Speed (Motion); Stroke; Structure; Suction; Surface; Surgical; Surgical Interventions; Surgical Procedure; System; System, Loinc Axis 4; Systematics; Techniques; Technology; Testing; Thromboembolism; Time; Transplantation; Vascular Accident, Brain; Ventricular; Weight; Zeugmatography; Adult Human (21+); Anatomy; Antepartum Diagnosis; Aortic Valve; Ascending Aorta; Base; Blood Loss; Blood Pump; Brain Attack; Cardiac Failure; Cerebral Vascular Accident; Children; Clinical Investigation; Commercialization; Computational Modeling; Computational Models; Computational Simulation; Computer Based Models; Computer Program/Software; Computerized Modeling; Computerized Simulation; Cost; Design; Designing; Device Development; Experiment; Experimental Research; Experimental Study; Heart Defect; Heart Disorder; Hemodynamics; Imaging; Improved; In Silico; In Vivo; Innovate; Innovation; Innovative; Instrument Development; Interventional Strategy; Minimally Invasive; Necropsy; Newborn Human (0-6 Weeks); Novel; Palliation; Palliative; Patient Population; Pediatric; Phase 1 Study; Postmortem; Pre-Clinical; Preclinical; Programs; Prototype; Public Health Relevance; Research Study; Safety Study; Single Functional Ventricle; Single Ventricle; Standard Of Care; Stroke; Success; Surgery; Transplant; Univentricular Heart; Ventricular Assist Device; Verification And Validation; Virtual Simulation; Youngster
