The subject of this work is development of a mechanical circulatory support system (MCSS) intended specifically for use in pediatric care, covering the needs of patients ranging from neonates to small children. A common opinion regarding devices currently approved for this class of patients is that they are disproportionately large, and in general, lack technical innovation associated with MCSSs used in adult care. The underpinnings for the present application are a series of successful in vitro and in vivo experiments conducted during the past 12 months by Nimbus and its development partner the University of Pittsburgh (UOP), which demonstrated the soundness of their pediatric blood pump concept. Now, in Phase II we intend to complete the basic design and validation of the product, and to accomplish a major portion of its device readiness testing in anticipation of clinical trials. Meeting these aims would verify that the pediatric blood pump concept is safe to be evaluated in IDE clinical trial. Such a trial would be the subject Of a Phase III program, wherein we would seek funding to complete the full regulatory requirements governing an IDE device, fabricate fully qualified hardware, determine component reliability levels, and conduct the clinical trial itself.
The new Nimbus product has potential commercial application in all hospitals, both in the U.S. and abroad, that perform neonatal-pediatric cardiac surgery.
