Research Project
3508715
DESCRIPTION (Adapted from applicant's abstract):This Phase II program will complete the development of a left ventricular assist system based on axial flow pump technology. It is a collaborative effort between Nimbus Medical, Inc., and the University of Pittsburgh's School of Medicine (UOP), a leading transplant center and clinical investigator of artificial hearts. The permanently implanted axial flow assist system will ultimately be used to treat patients with terminal cardiomyopathy. Feasibility of the system has been demonstrated during Phase I through three in vivo experiments (1-14 days) and an in vitro durability test of 90 days. The wear of bearing and seal surfaces is compatible with at least two years of life. After Phase II, sufficient development will have been completed to begin a formal qualification program to gain FDA approval for clinical trials. During Phase III, the assist system will enter clinical trails for use as a bridge to cardiac transplantation and as a permanent implant to treat patients with terminal cardiomyopathy. Phase III will complete clinical trials and begin commercialization of the axial flow assist system. An annual gross business in the range of $100 million is projected based on the incidence cardiomyopathy in the United States.
