In early 2000, Lois Spiller, a retired financial analyst, was 52 years old, her heart was enlarged, and she was suffering from cardiomyopathy. Ms. Spiller became the first participant in the U.S. clinical trial of the Jarvik 2000 FlowMakerŪ.
She received the implanted assist device at the Texas HeartŪ Institute. Seventy-nine days later, the device was explanted when a donor heart was found. Ms. Spiller survived the heart transplant operation and has since resumed a normal life.
In the years following Ms. Spiller's operation, Texas Heart and other leading medical institutions throughout the country have performed numerous similar operations. In the U.S., the Jarvik 2000 is used only as a bridge-to-transplant device under the terms of an FDA-approved clinical investigation. To be eligible for the study, patients must be on the transplant waiting list suffering end-stage heart failure. (Photo of Lois Spiller courtesy of Texas HeartŪ Institute.)