Development of an Infant VAD System for Long Term Uni- and Bi-ventricular Support

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R44HL106942-01
Agency Tracking Number: R44HL106942
Amount: $217,048.00
Phase: Phase I
Program: SBIR
Awards Year: 2011
Solicitation Year: 2011
Solicitation Topic Code: NHLBI
Solicitation Number: PA10-050
Small Business Information
1635 ENERGY PARK DRIVE, ST. PAUL, MN, 55108-2703
DUNS: 945753622
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 (651) 251-9227
Business Contact
Phone: (651) 251-9227
Research Institution
DESCRIPTION (provided by applicant): Development of an Infant VAD System for Long Term Uni- and Bi-ventricular Support Project Summary This objective of the project is to develop a Ventricular Assist System (VAS) for supporting infants with severe heart failure. The VAS consists of an Infant-sized Ventricular Assist Device (VAD) which can be used to support the left ventricle or right ventricle, or both ventricles (biventricular support), and a portable BiVAD driver which can power left and right VADs. Although VADs have been successfully used for adult heart-failure patients for over 30 years, their introduction to pediatrics has been slow to evolve. The pneumatically-actuated, pulsatile VAD is well-suited to the pediatric application, especially in infants. It may be utilized for right, left, or bi-ventricular support. Penn State and Minnetronix have developed a pulsatile pneumatic sac-type pediatric Ventricular Assist System based on the design of the adult-sized Pierce-Donachy (Thoratec(R)) VAD. The Infant VAD has a dynamic stroke volume of 14 ml, and is capable of supporting the circulation for periods up to one year. This work extends that development to a portable pneumatic driver and control system which will complete the development of the infant VASin preparation for pre-clinical testing. The driver will incorporate innovative features to automatically optimize the pump operation to achieve maximum flow rate under all preload conditions, and minimize thrombembolic risk, including during weaning. Special emphasis will be placed on usability in pediatric heart centers unfamiliar with VAD systems. PUBLIC HEALTH RELEVANCE: The pediatric Ventricular Assist Device (VAD) will provide a currently-unavailable option for safe, long term support for infants with failing hearts or congenital heart defects. Because it will be able to safely replace the function of both pumping chambers of the heart for extended periods of time, this system will provide a valuable new care option.

* Information listed above is at the time of submission. *

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