Few total artificial hearts make it to human
clinical trials, and only the SynCardia Total Artificial Heart has
met the rigorous requirements for commercial approval.
TUCSON,
Ariz., July 25, 2024 /PRNewswire/ -- Nearly
twenty years ago, the SynCardia Total Artificial Heart became
the first total artificial heart to receive commercial approval
from the U.S. Food & Drug Administration (FDA). Since then, a
number of experimental total artificial hearts have come and gone,
but unlike the SynCardia Total Artificial Heart, none have been
able to achieve commercial approval nor widespread clinical
use.
"Completely implantable heart replacement therapy is the zenith
in the world of artificial organs," said Patrick Schnegelsberg, CEO of SynCardia. "The
Total Artificial Heart we have developed is the first and remains
the only commercially available device. Our vision is to build on
our experience and proven technology to make our dream of fully
implantable technology a reality."
The SynCardia Total Artificial Heart received FDA approval on
Oct. 15, 2004, following a 10-year
pivotal clinical study. According to the study results, which were
published in the New England Journal of Medicine on
Aug. 26, 2004, of the 81 patients who
received the SynCardia Total Artificial Heart, 79% were bridged to
a heart transplant. In comparison, only 46% of the control patients
who did not receive the device survived to transplantation.
Overall, the one-year survival rate post-transplant among the
clinical study patients who received the SynCardia Total Artificial
Heart was 70% compared with only 31% of patients who did not
receive the device prior to receiving a heart transplant. One-year
and five-year survival rates after transplantation among patients
who received the SynCardia Total Artificial Heart were 86% and 64%,
respectively.
More recent studies in the US and in Europe have confirmed these results in
real world populations.
Today, there have been more than 2,000 implants of the SynCardia
Total Artificial Heart at more than 130 hospitals across 25
countries.
Over the years, several experimental total artificial hearts
have made headlines but have yet to achieve commercial success and
have remained in clinical trials.
About SynCardia
The SynCardia Total Artificial Heart
is the first and only commercially available FDA and Health Canada
approved total artificial heart. It is available in two sizes, to
accommodate a wide variety of patients providing cardiac output
flows up to 9 lpm.
The SynCardia Total Artificial Heart has been implanted in over
2,000 patients across 20 countries and has provided 293,997 days of
life to patients with heart failure. Powered by the Freedom
Portable Driverâ„¢, the SynCardia Total Artificial Heart has allowed
many patients to live at home while waiting for a donor heart
including a patient currently at home with his family who has been
supported by the SynCardia Total Artificial Heart since 2017. To
learn more, visit www.syncardia.com and follow us on Facebook,
X, and LinkedIn.
Media Contact:
Vivian
Highton
vhighton@syncardia.com
520-955-3634
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content:https://www.prnewswire.com/news-releases/20-years-after-landmark-fda-approval-syncardia-remains-worlds-only-commercially-approved-total-artificial-heart-302206912.html
SOURCE SynCardia Systems, LLC