The goal of the new contract, he says, is to complete the studies by the year 2000 and then apply for permission from the Food and Drug Administration to begin human clinical trials. The air-driven Penn State Heart is one of only two artificial hearts approved by the FDA for use in humans as a temporary bridge to a heart transplant. According to Rosenberg, both laboratory and animal testing will continue. Before human clinical trials become a reality, he and his research group will have to run the electric heart through its paces, beginning with long-term testing on a mock circulatory system that was used to verify the operation of the device before it was implanted in animals. The heart is powered by a battery kept near the recipient.
Energy is transmitted from the battery across the intact skin by a pair of wire coils.
This energy is used by an implanted electronic control system to power the small electric motor that provides the force for the blood pump, A battery, housed in the same container as the electronics, provides about 30 minutes of operation when the external coil is removed. Some of the changes will likely involve the external battery pack. Specifically, we'll look at whether it is a comfortable, user-friendly system. Now we have a completely implantable system.