| 1957:
At Cleveland Clinic, Dr. Willem J. Kolff and Dr. Tetsuzo
Akutsu bring the concept of a total artificial heart
to reality through a series of animal implants. One
animal survives for approximately 90 minutes.
1963: Ventriloquist Paul
Winchell is granted the first patent for an artificial
heart. Winchell's work is aided by Dr. Henry Heimlich,
who later develops the Heimlich maneuver to save choke
victims. Years later, Winchell signs over his patent
rights to Dr. Kolff at the University of Utah (U of
U).
1967: Christiaan Barnard
performs the first heart transplant in Cape Town, South
Africa. The patient lives 18 days.
1969: Dr. Denton Cooley
at the Texas Heart Institute becomes the first heart
surgeon to implant an artificial heart in a human subject.
1979: The Jarvik TAH is
designed using a flexible four-layer diaphragm and a
structural design that fits in the human chest. This
design was a larger 100cc version of today's CardioWest
TAH‑t, which is 70cc.
1982: Dr. William D. DeVries
receives approval from the FDA to perform the first
permanent artificial heart implant using the Jarvik
7 TAH. Barney Clark lives 112 days on this device.
1983: Between 1976 and
1983, more than 200 calves are implanted with the Jarvik
5 and Jarvik 7 versions of the artificial heart that
are driven by Utah Drive heart controllers.
1985: At the University
of Arizona, Dr. Jack Copeland implants a prototype TAH
in a patient who had rejected a recently transplanted
heart. This device, later called the Phoenix TAH, bridges
the patient to another heart transplant after 11 hours
of support. Later that year, Copeland successfully bridges
a patient to transplant using a Jarvik 7 heart.
1985: The FDA gives approval
for Hershey Medical Center to perform six Penn State
artificial heart implants as bridges to human heart
transplants. This heart is no longer used with human
subjects.
1990-1992: The FDA withdraws
the Investigational Device Exemption (IDE) from Symbion
for the clinical study of the Jarvik TAH. Symbion subsequently
donates the TAH technology to University Medical Center
(UMC), Tucson, AZ, which reincorporates the company
and renames it CardioWest.
1993-2002: CardioWest
receives an IDE from the FDA to study the TAH. Eighty-one
patients received the TAH as a bridge to transplant
with 35 control patients who did not receive the TAH.
2001: The TAH technology
is spun out of UMC with private investments and SynCardia
Systems, Inc. is formed by Dr. Marvin J. Slepian along
with Richard G. Smith, MSEE, CCE, and cardiovascular
surgeon Dr. Jack Copeland. The IDE is transferred to
SynCardia.
2004 August: The New England
Journal of Medicine publishes the results of the IDE
study. In the pivotal clinical trial, the one-year survival
rate following human heart transplants for patients
receiving the TAH was 70 percent versus 31 percent for
control patients.
2004 October: The CardioWest
TAH‑t becomes the world's first and only FDA approved
temporary Total Artificial Heart. The indication for
use is as a bridge to transplant in cardiac transplant
patients at risk of imminent death from non-reversible
biventricular failure.
2006: The number of CardioWest™certified
centers grows to 20 transplant centers worldwide.
2007: By the end of the year, 30 transplant centers were either CardioWest certified or in the process of completing CardioWest certification training.
2008: SynCardia projects that by the end of the year, 40 transplant centers will either be CardioWest certified or in the process of completing certification training.
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