SBIR-STTR Award

Advances in ventricular assist device (VAD) technology during the last decade have been largely limited to concepts intended for the adult population. Options for mechanical support of pediatric patients with severe heart failure, and especially those who are awaiting cardiac transplantation, are extremely limited. The primary limitation to the use of currently available VADs for pediatric bridging-to-cardiac transplantation is the excessive size of these devices.Devices are needed that are specifically intended to meet the special size and hemodynamic requirements of the pediatric population. To that end, Nimbus, Inc. and its development partner, the University of Pittsburgh, have capitalized on their collective experience in axial flow and centrifugal blood pump technology, use of VADs in the clinical setting, and pediatric cardiac transplantation to design a prototype, miniaturized VAD suitable for implantation in pediatric aged patients. Our aims are to demonstrate via in vitro performance testing and in vivo implants the feasibility of this innovative design for pediatric, bridge-to-transplant circulatory support. If ultimately successful, this pump would have commercial application as a product marketed to hospitals in the United States and abroad. .National Heart, Lung, and Blood Institute (NHLBI)

This Phase II project involves development and pre-clinical qualification of a left ventricular assist system (LVAS) that features a miniature axial flow blood pump with simplified (e.g., blood-immersed) bearings. In Phase I convincing evidence was obtained demonstrating the feasibility of this new axial flow pump. In particular the results of several in vivo tests, including one of 2-months duration and one ongoing experiment approaching 5 months, indicate the pump's potential to operate in blood for periods of time consistent with clinical bridge-to-transplant (BTT) applications. Now in Phase II the goals are to complete development of this LVAS and conduct sufficient in vitro and animal testing to document its overall safety and performance, in anticipation of a clinical trial for BTT applications lasting up to 90 days. In addition to the pump, the LVAS consists of inflow/outflow cannulae and externally worn components, e.g., primary battery, back-up battery, and pump controller, which provide power and closed-loop speed control of the implanted pump. A small diameter percutaneous wire connects the implanted pump to the external controller. If ultimately successful, this new LVAS would be vastly simpler, smaller, and less costly than the products available today for clinical use. PROPOSED COMMERCIAL APPLICATION: The bridge-to-transplant application would only be the first use of this type of LVAS to treat heart failure patients. Beyond bridge-to-transplant applications, the LVAS would then be qualIfied for use as an alternative-to-transplant. This latter application has a very large commercial potential and is the most significant for this device.

Thesaurus Terms:
auxiliary heart prosthesis, biomedical equipment development, nonhuman therapy evaluation implant cow